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Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)

NCT00941603 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 619

Last updated 2018-09-25

Study results available
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Summary

The purpose of this study is to evaluate the effect of SCH 900271 compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 8 weeks of treatment in participants with primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia. The study will also evaluate the effect of SCH 900271 on non-high density lipoprotein cholesterol (non-HDL-C) and various other lipids and lipoproteins. The safety of SCH 900271 in this participant population will also be evaluated.

Conditions

  • Primary Hypercholesterolemia
  • Mixed Hyperlipidemia

Interventions

DRUG

SCH 900271 15mg

oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks

DRUG

SCH 900271

oral tablets; SCH 900271 10 mg taken once daily for 8 weeks

DRUG

SCH 900271

oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks

DRUG

SCH 900271

oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks

DRUG

SCH 900271

oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks

DRUG

Placebo

oral tablets; placebo administered once daily during the 5-week single-blind placebo run-in and diet stabilization period and during the 8 week double-blind treatment period.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-29
Primary Completion
2010-02-22
Completion
2010-02-22

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00941603 on ClinicalTrials.gov