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A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01651273
Recruitment Status : Terminated
First Posted : July 27, 2012
Last Update Posted : August 5, 2013
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE July 13, 2012
First Posted Date  ICMJE July 27, 2012
Last Update Posted Date August 5, 2013
Study Start Date  ICMJE November 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2012)
  • Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy [ Time Frame: Up to 56 days of study participation ]
  • Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy [ Time Frame: Up to 30 days post discontinuation of dosing or last participation in the study for serious adverse events collection ]
  • Number and percent of subjects with potentially clinically significant changes in ECG parameter [ Time Frame: Upto 56 days ]
    Electrocardiogram (ECG) parameters defined as:
    • Investigator identified clinically significant abnormalities
    • QTcF> 480 msec or QTcF changes from baseline> 60 msec
    • QRS (msec): QRS> 120 msec
    • PR (msec): PR > 210 msec
  • Number and percent of subjects with potentially clinically significant changes in low density lipoprotein (LDL)-c (measured) [ Time Frame: Upto 56 days ]
    LDL-c (measured) defined as:
    • LDL-c (mg/dL): LDL-c percent changes from baseline >= 15%
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2012)
  • Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data [ Time Frame: Days 7, 14, 21 and 28 ]
  • Area under the concentration-time curve from zero (pre-dose) to 8 h [AUC(0-8h)] of BMS-852927 will be derived from plasma concentration versus time data [ Time Frame: Days 1 and 28 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia
Official Title  ICMJE A Site and Subject Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS 852927 in Patients With Primary Hypercholesterolemia on a Stable Dose of Statin Therapy
Brief Summary The purpose of this study is to evaluate the safety of BMS-852927 after 28 days of dosing in patients with high cholesterol.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Drug: BMS-852927
    Capsules, Oral, 0.25 mg, Once daily, 28 days
  • Drug: BMS-852927
    Capsules, Oral, 1.0 mg, Once daily, 28 days
  • Drug: BMS-852927
    Capsules, Oral, 2.5 mg, Once daily, 28 days
  • Drug: Placebo
    Capsules, Oral, 0 mg, Once daily, 28 days
Study Arms  ICMJE
  • Experimental: Arm 1: BMS-852927 (0.25 mg)
    Intervention: Drug: BMS-852927
  • Experimental: Arm 2: BMS-852927 (1.0 mg)
    Intervention: Drug: BMS-852927
  • Experimental: Arm 3: BMS-852927 (2.5 mg)
    Intervention: Drug: BMS-852927
  • Placebo Comparator: Arm 4: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 2, 2013)
97
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2012)
168
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women, aged ≥18 to ≤75
  • Body mass index (BMI) ≤ 40 kg/m2
  • Primary hypercholesterolemia on a stable daily dose of a statin for ≥ 6 weeks
  • Serum triglyceride levels at screening < 400mg/dL (< 4.52 mmol/L)

Exclusion Criteria:

  • Any significant acute medical illness, significant cardiovascular history
  • Current or history of hepatic or hepatobiliary disease
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01651273
Other Study ID Numbers  ICMJE CV201-008
2012-001946-17 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP