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A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01651273
First received: July 13, 2012
Last updated: August 2, 2013
Last verified: August 2013
July 13, 2012
August 2, 2013
November 2012
June 2013   (Final data collection date for primary outcome measure)
  • 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%
Same as current
Complete list of historical versions of study NCT01651273 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia
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
The purpose of this study is to evaluate the safety of BMS-852927 after 28 days of dosing in patients with high cholesterol.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
97
June 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany
 
 
NCT01651273
CV201-008
2012‐001946‐17 ( EudraCT Number )
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2013

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