Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

ID: NCT01345929
Status: Completed
Phase: Phase 3
Start Date: June 01, 2011
First Submitted: April 28, 2011
Last Updated: March 29, 2017
Results: Available
Success Rate: 96%
Sponsors & Collaborators: Cubist Pharmaceuticals LLC
Location: Brazil, Colombia, Estonia, Georgia, Germany, Hungary, Israel, Latvia, Mexico, Moldova, Republic of, Romania, Russian Federation, Serbia, Slovakia, South Africa, Thailand, United States
Conditions: Complicated Urinary Tract Infection, Pyelonephritis
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Study Description

Brief Summary

This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including pyelonephritis).

Detailed Description

Approximately 500 subjects will be enrolled into this study and randomized 1:1 to receive CXA-201 or comparator (levofloxacin) resulting in 250 subjects per treatment arm. Subject participation will require a minimum commitment of 35 days and a maximum of 42 days. Subjects will be hospitalized for the administration of all doses of IV study therapy. A test of cure visit will occur at 7 days after the last dose of study drug and a late follow-up evaluation or contact will occur a minimum of 28 days and a maximum of 35 days after the last dose of study drug.
Condition or disease Intervention/treatment Phase

Complicated Urinary Tract Infection

Pyelonephritis

Drug: CXA-201
Other Names
Drug: Levofloxacin
Other Names
Phase 3

Tracking Information

First Submitted DateApril 28, 2011
Last Update Posted DateMarch 29, 2017
Actual Start DateJune 01, 2011
Actual Completion DateSeptember 01, 2013
Actual Primary Completion DateAugust 01, 2013
Results First Submitted DateJanuary 09, 2015
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population [Time Frame: Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)]

Original Primary Outcome Measures

  • The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population

Current Secondary Outcome Measures

  • The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population. [Time Frame: Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)]

Original Secondary Outcome Measures

  • The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population.

Study Design

Brief TitleStudy Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis
Official TitleA Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis
Brief Summary

This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including pyelonephritis).

Detailed Description

Approximately 500 subjects will be enrolled into this study and randomized 1:1 to receive CXA-201 or comparator (levofloxacin) resulting in 250 subjects per treatment arm. Subject participation will require a minimum commitment of 35 days and a maximum of 42 days. Subjects will be hospitalized for the administration of all doses of IV study therapy. A test of cure visit will occur at 7 days after the last dose of study drug and a late follow-up evaluation or contact will occur a minimum of 28 days and a maximum of 35 days after the last dose of study drug.

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
558
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Complicated Urinary Tract Infection
Pyelonephritis
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: CXA-201

CXA-201 IV infusion (1500mg q8) for 7 days

Other Names
Drug: Levofloxacin

Levofloxacin IV infusion (750mg qd) for 7 days

Other Names
Study Groups/Cohorts
CXA-201 as treatment for cUTI
CXA-201 IV infusion (1500mg q8) for 7 days

Levofloxacin as treatment for cUTI
Levofloxacin IV infusion (750mg qd) for 7 days

Study Arms
Experimental CXA-201 as treatment for cUTI
CXA-201 IV infusion (1500mg q8) for 7 days
Drug : CXA-201
CXA-201 IV infusion (1500mg q8) for 7 days

Active Comparator Levofloxacin as treatment for cUTI
Levofloxacin IV infusion (750mg qd) for 7 days
Drug : Levofloxacin
Levofloxacin IV infusion (750mg qd) for 7 days

Arm Intervention/Treatment
Experimental CXA-201 as treatment for cUTI
CXA-201 IV infusion (1500mg q8) for 7 days
Drug : CXA-201
Active Comparator Levofloxacin as treatment for cUTI
Levofloxacin IV infusion (750mg qd) for 7 days
Drug : Levofloxacin

Recruitment Information

Recruitment Status:Completed
Enrollment558
Completion DateSeptember 01, 2013
Eligibility Criteria: Inclusion Criteria:
1. Provide written informed consent prior to any study-related procedure not part of normal medical care (a legally acceptable representative may provide consent if the subject is unable to do so, provided this is approved by local country and institution specific guidelines).
2. Be males or females ≥ 18 years of age
3. If female, subject is non-lactating, and is either:
1. Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or
2. Of childbearing potential and is practicing a barrier method of birth control (e.g., a diaphragm or contraceptive sponge) along with 1 of the following methods: oral or parenteral contraceptives (for 3 months prior to study drug administration), or a vasectomized partner. Or, subject is practicing abstinence from sexual intercourse. Subjects must be willing to practice these methods for the duration of the trial and for at least 35 days after last dose of study medication.
4. Males are required to practice reliable birth control methods (condom or other barrier device) during the conduct of the study and for at least 35 days after last dose of study medication.
5. Pyuria (white blood cell [WBC] count > 10/μL in unspun urine or ≥ 10 per high power field in spun urine).
6. Clinical signs and/or symptoms of cUTI, either of:
1. Pyelonephritis, as indicated by at least 2 of the following:
- Documented fever (oral temperature > 38°C) accompanied by patient symptoms of rigors, chills, or "warmth";
- Flank pain;
- Costovertebral angle tenderness or suprapubic tenderness on physical exam; or
- nausea or vomiting; OR
2. Complicated lower UTI, as indicated by at least 2 of the following:
- At least 2 of the following new or worsening symptoms of cUTI:
- Dysuria; urinary frequency or urinary urgency;
- Documented fever (oral temperature > 38°C) accompanied by patient symptoms of rigors, chills, or "warmth";
- Suprapubic pain or flank pain;
- Costovertebral angle tenderness or suprapubic tenderness on physical exam; or
- Nausea or vomiting; plus,
- At least 1 of the following complicating factors:
- Males with documented history of urinary retention;
- Indwelling urinary catheter that is scheduled to be removed during IV study therapy and before the EOT;
- Current obstructive uropathy that is scheduled to be medically or surgically relieved during IV study therapy and before the EOT; or
- Any functional or anatomical abnormality of the urogenital tract (including anatomic malformations or neurogenic bladder) with voiding disturbance resulting in at least 100 mL residual urine.
7. Have a pretreatment baseline urine culture specimen obtained within 24 hours before the start of administration of the first dose of study drug.
NOTE: Subjects may be enrolled in this study and start IV study drug therapy before the Investigator knows the results of the baseline urine culture.
8. Require IV antibacterial therapy for the treatment of the presumed cUTI.

Exclusion Criteria:
1. Have a documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam or quinilone antibacterial (Note: for β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment)
2. Have a concomitant infection at the time of randomization, which requires non-study systemic antibacterial therapy in addition to IV study drug therapy. (Drugs with only gram-positive activity [e.g., vancomycin, linezolid] are allowed.)
3. Receipt of any amount of potentially therapeutic antibacterial therapy after collection of the pretreatment baseline urine culture and before administration of the first dose of study drug.
4. Receipt of any dose of a potentially therapeutic antibacterial agent for the treatment of the current UTI within 48 hours before the study-qualifying pretreatment baseline urine is obtained (exceptions: subjects with an active cUTI who have received prior antibiotics may be enrolled provided a minimum of 48 hours have elapsed between the last dose of the prior antibiotic and the time of obtaining the baseline urine specimen. Subjects receiving current antibiotic prophylaxis for cUTI who present with signs and symptoms consistent with an active new cUTI may be enrolled provided all other eligibility criteria are met including obtaining a pre-treatment qualifying baseline urine culture).
5. Intractable urinary infection at baseline that the Investigator anticipates would require more than 7 days of study drug therapy.
6. Complete, permanent obstruction of the urinary tract.
7. Confirmed fungal urinary tract infection at time of randomization (with ≥ 103 fungal CFU/mL).
8. Permanent indwelling bladder catheter or urinary stent including nephrostomy.
9. Suspected or confirmed perinephric or intrarenal abscess.
10. Suspected or confirmed prostatitis.
11. Ileal loop or known vesico-ureteral reflux.
12. Severe impairment of renal function including an estimated CrCl < 30 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20 mL/h urine output over 24 hours).
13. Current urinary catheter that is not scheduled to be removed before the EOT (intermittent straight catheterization during the IV study drug administration period is acceptable).
14. Any condition or circumstance that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of study data.
15. Any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure, respiratory failure, and septic shock.
16. Immunocompromising condition, including established AIDS, hematological malignancy, or bone marrow transplantation, or immunosuppressive therapy including cancer chemotherapy, medications for prevention of organ transplantation rejection, or the administration of corticosteroids equivalent to or greater than 40 mg of prednisone per day administered continuously for more than 14 days preceding randomization.
17. One or more of the following laboratory abnormalities in baseline specimens: aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase, or total bilirubin level greater than 3 times the upper limit of normal (ULN), absolute neutrophil count less than 500/μL, platelet count less than 40,000/μL, or hematocrit less than 20%.
18. Participation in any clinical study of an investigational product within 30 days prior to the proposed first day of study drug.
19. Previous participation in any study of CXA-101 or CXA-201.
20. Women who are pregnant or nursing.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Brazil
Colombia
Estonia
Georgia
Germany
Hungary
Israel
Latvia
Mexico
Moldova, Republic of
Romania
Russian Federation
Serbia
Slovakia
South Africa
Thailand
United States

Administrative Information

NCT Number:NCT01345929
Other Study ID Numbers
7625A-005
CXA-cUTI-10-04
CXA-cUTI-10-05
NCT01345955
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Cubist Pharmaceuticals LLC
Collaborators
Not Available
Investigators
Study Director
Obiamiwe Umeh, M.D., MSc.
Cubist Pharmaceuticals LLC

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Not Available

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two P3 protocols were initiated (NCT01345929 and NCT01345955) subsequently, Cubist and FDA agreed that integrated data from the 2 protocols could be analyzed and reported in a single Clinical Study Report. A total of 1083 subjects were randomized to both arms, 558 to NCT01345929 and 525 to NCT01345955. Of these, 552 and 516 received treatment.

Reporting Groups

TitleDescription
CXA-201 as Treatment for cUTI
CXA-201 IV infusion (1500mg q8) for 7 days CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days Of the 1083 subjects in the integrated analysis set, 533 received CXA.
Levofloxacin as Treatment for cUTI
Levofloxacin IV infusion (750mg qd) for 7 days Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days Of the 1083 subjects in the integrated analysis set, 535 received levofloxacin.

Participant Flow: Overall

CXA-201 as Treatment for cUTILevofloxacin as Treatment for cUTI
Started533535
Completed512516
Not Completed2119
40,000 CFU/ML10
Adverse Event01
Didn't meet eligibility criteria20
Lost to Follow-up99
Patient withdrawal01
Withdrawal by Subject98

Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Not Available

Reporting Groups

TitleDescription
CXA-201 as Treatment for cUTI
CXA-201 IV infusion (1500mg q8) for 7 days CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days
Levofloxacin as Treatment for cUTI
Levofloxacin IV infusion (750mg qd) for 7 days Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days
Total
Total of all reporting groups

Baseline Measures

CXA-201 as Treatment for cUTILevofloxacin as Treatment for cUTITotal
Overall Participants Analyzed
Units: Participants
Participants Analyzed
5335351068
5335351068
Age
Units: years - Mean (Standard Deviation)
Participants Analyzed
5335351068
49.7 (19.52)48.6 (20.05)49.1 (19.79)
Sex: Female, Male
Units: Participants - Count of Participants
Participants Analyzed
5335351068
Female374380754
Male159155314

Outcome Measures

1. Primary: The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population

Measure Type
Primary
Measure Title
The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population
Measure Description
Not Available
Time Frame
Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mMITT: Treated subjects, with baseline pathogen.

Reporting Groups

TitleDescription
CXA-201 as Treatment for cUTI
CXA-201 IV infusion (1500mg q8) for 7 days CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days
Levofloxacin as Treatment for cUTI
Levofloxacin IV infusion (750mg qd) for 7 days Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days

Outcome Measures

CXA-201 as Treatment for cUTILevofloxacin as Treatment for cUTI
Participants Analyzed
Units: Participants
398402
The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population
Units: percentage of subjects - Number
76.968.4

Statistical Analysis

Groups
All Groups
Statistical Test Type
Non-Inferiority or Equivalence
Statistical Method
Not Available
P Value
Not Available
Risk Difference (RD)
8.50000
95% Confidence Interval
2.31000 to 14.57000
  1. Additional details about the analysis, such as null hypothesis and power calculation
    Not Available
  2. Details of power calculation, definition of non-inferiority margin, and other key parameters
    Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.
  3. Other relevant method information, such as adjustments or degrees of freedom
    Not Available
  4. Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance
    Not Available
  5. Other relevant estimation information
    Not Available

2. Secondary: The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population.

Measure Type
Secondary
Measure Title
The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population.
Measure Description
Not Available
Time Frame
Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ME: Treated patients, with baseline pathogen, complied with protocol.

Reporting Groups

TitleDescription
CXA-201 as Treatment for cUTI
CXA-201 IV infusion (1500mg q8) for 7 days CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days
Levofloxacin as Treatment for cUTI
Levofloxacin IV infusion (750mg qd) for 7 days Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days

Outcome Measures

CXA-201 as Treatment for cUTILevofloxacin as Treatment for cUTI
Participants Analyzed
Units: Participants
341353
The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population.
Units: percentage of subjects - Number
83.375.4

Statistical Analysis

Groups
All Groups
Statistical Test Type
Non-Inferiority or Equivalence
Statistical Method
Not Available
P Value
Not Available
Risk Difference (RD)
8.00000
95% Confidence Interval
1.95000 to 13.97000
  1. Additional details about the analysis, such as null hypothesis and power calculation
    Not Available
  2. Details of power calculation, definition of non-inferiority margin, and other key parameters
    Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.
  3. Other relevant method information, such as adjustments or degrees of freedom
    Not Available
  4. Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance
    Not Available
  5. Other relevant estimation information
    Not Available

Serious Adverse Events

Time Frame
Not Available
Additional Description
Not Available
Frequency Threshold0% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
CXA-201 as Treatment for cUTI
CXA-201 IV infusion (1500mg q8) for 7 days CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days
Levofloxacin as Treatment for cUTI
Levofloxacin IV infusion (750mg qd) for 7 days Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days

Serious Adverse Events

CXA-201 as Treatment for cUTILevofloxacin as Treatment for cUTI
Total, serious adverse events
No. of participants affected / at risk15/533 (0.00%)18/535 (0.00%)
Angina unstable
No. of participants affected / at risk0/533 (0.00%)1/535 (0.00%)
Cardiac failure congestive
No. of participants affected / at risk0/533 (0.00%)1/535 (0.00%)
Diabetic retinopaty
No. of participants affected / at risk1/533 (0.00%)0/535 (0.00%)
Gastric ulcer
No. of participants affected / at risk0/533 (0.00%)1/535 (0.00%)
Hernia obstructive
No. of participants affected / at risk0/533 (0.00%)1/535 (0.00%)
Contrast media allergy
No. of participants affected / at risk0/533 (0.00%)1/535 (0.00%)
Urinary tract infection
No. of participants affected / at risk3/533 (0.00%)2/535 (0.00%)
Pneumonia
No. of participants affected / at risk2/533 (0.00%)0/535 (0.00%)
Urosepsis
No. of participants affected / at risk2/533 (0.00%)0/535 (0.00%)
Abdominal abscess
No. of participants affected / at risk1/533 (0.00%)0/535 (0.00%)
Clostridium difficile colitis
No. of participants affected / at risk1/533 (0.00%)0/535 (0.00%)
Diverticulitis
No. of participants affected / at risk1/533 (0.00%)0/535 (0.00%)
Liver abscess
No. of participants affected / at risk1/533 (0.00%)0/535 (0.00%)
Pseudomembranous colitis
No. of participants affected / at risk1/533 (0.00%)0/535 (0.00%)
Pyelonephritis
No. of participants affected / at risk0/533 (0.00%)6/535 (0.00%)
Emphysematous pyelonephritis
No. of participants affected / at risk0/533 (0.00%)1/535 (0.00%)
Escherichia sepsis
No. of participants affected / at risk0/533 (0.00%)1/535 (0.00%)
Pyelonephritis acute
No. of participants affected / at risk0/533 (0.00%)1/535 (0.00%)
Sepsis
No. of participants affected / at risk0/533 (0.00%)1/535 (0.00%)
Pneumothorax traumatic
No. of participants affected / at risk0/533 (0.00%)1/535 (0.00%)
Bladder cancer
No. of participants affected / at risk2/533 (0.00%)0/535 (0.00%)
Transient ischaemic attack
No. of participants affected / at risk0/533 (0.00%)1/535 (0.00%)
Calculus urinary
No. of participants affected / at risk1/533 (0.00%)0/535 (0.00%)
Renal colic
No. of participants affected / at risk1/533 (0.00%)0/535 (0.00%)
Urinary retention
No. of participants affected / at risk1/533 (0.00%)0/535 (0.00%)
Renal tubular acidosis
No. of participants affected / at risk0/533 (0.00%)1/535 (0.00%)
Chronic obstructive pulmonary disease
No. of participants affected / at risk0/533 (0.00%)1/535 (0.00%)

Other Adverse Events

Time Frame
Not Available
Additional Description
Not Available
Frequency Threshold1% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
CXA-201 as Treatment for cUTI
CXA-201 IV infusion (1500mg q8) for 7 days CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days
Levofloxacin as Treatment for cUTI
Levofloxacin IV infusion (750mg qd) for 7 days Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days

Other Adverse Events

CXA-201 as Treatment for cUTILevofloxacin as Treatment for cUTI
Total, other adverse events
No. of participants affected / at risk108/533 (0.00%)101/535 (0.00%)
Abdominal pain upper
No. of participants affected / at risk7/533 (0.00%)6/535 (0.00%)
Constipation
No. of participants affected / at risk21/533 (0.00%)17/535 (0.00%)
Diarrhoea
No. of participants affected / at risk10/533 (0.00%)23/535 (0.00%)
Nausea
No. of participants affected / at risk15/533 (0.00%)9/535 (0.00%)
Vomiting
No. of participants affected / at risk6/533 (0.00%)6/535 (0.00%)
Pyrexia
No. of participants affected / at risk8/533 (0.00%)4/535 (0.00%)
Urinary tract infection
No. of participants affected / at risk6/533 (0.00%)7/535 (0.00%)
Alanine aminotransferase increased
No. of participants affected / at risk9/533 (0.00%)5/535 (0.00%)
Aspartate aminotransferase increased
No. of participants affected / at risk9/533 (0.00%)5/535 (0.00%)
Arthralgia
No. of participants affected / at risk1/533 (0.00%)6/535 (0.00%)
Myalgia
No. of participants affected / at risk6/533 (0.00%)4/535 (0.00%)
Dizziness
No. of participants affected / at risk6/533 (0.00%)1/535 (0.00%)
Headache
No. of participants affected / at risk31/533 (0.00%)26/535 (0.00%)
Insomnia
No. of participants affected / at risk7/533 (0.00%)14/535 (0.00%)
Hypertension
No. of participants affected / at risk16/533 (0.00%)7/535 (0.00%)

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.
The investigator(s) must undertake not to submit any part of the data from this protocol for publication without the prior consent of Cubist Pharmaceuticals, Inc.

Results Point of Contact

Name/TitleOrganizationPhoneEmail
Dr. Obi Umeh, Vice President Global Medical Sciences
Cubist Pharmaceuticals, Inc.
781-860-8415