Safety Study of BMS-823778 in Subjects With Hypercholesterolemia

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Dyslipidemia

Treatments: Drug: BMS-823778; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01112423

MB121-003

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypercholesterolemia
• Currently taking a stable daily dose of statin therapy
• Serum triglyceride level < 500mg/dl

Exclusion criteria

• History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study
• Congestive heart failure
• Diabetes mellitus
• Active liver disease
• Impaired renal function
• Hepatitis C, B and HIV

This list is not inclusive; additional information is provided in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 4 patient groups, including a placebo group

BMS-823778 (2 mg)

Experimental group

Treatment:

Drug: BMS-823778

Drug: BMS-823778

Drug: BMS-823778

BMS-823778 (10 mg)

Experimental group

Treatment:

Drug: BMS-823778

Drug: BMS-823778

Drug: BMS-823778

BMS-823778 (20 mg)

Experimental group

Treatment:

Drug: BMS-823778

Drug: BMS-823778

Drug: BMS-823778

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo