A 2-year Extension to: A 76-week Study to Assess the Tolerability and Efficacy of Anacetrapib When Added to Ongoing Therapy in Patients with Hypercholesterolemia or Mixed Hyperlipidemia: Reversal period extended from 12 weeks to 1-year

Phase 1

• Conditions: Hypercholesterolemia, mixed hyperlipidemia; MedDRA version: 16.1Level: LLTClassification code 10003601Term: AtherosclerosisSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2007-005839-28-NL
• Lead Sponsor: Merck, Sharp & Dohme b.v.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-18
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. Patient has completed the P019-base study including the reversibility period (i.e. 12 or to up to 24 weeks).
2. Patient is on statin therapy ± lipid-modifying therapy since the end of the base study and planning to continue taking a statin throughout the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient has developed any medical condition or disorder that, in the opinion of the investigator or Merck Clinical Monitor, might pose a risk to the patient.
2. Patient is currently participating in a study with another investigational drug.
3. Patient is on or likely to require prohibited medication (see Appendix 6.7).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: After 2-years of the extension study:<br>To assess the safety and tolerability of anacetrapib 100 mg.;Secondary Objective: After 2-years of the extension study:<br>1. To evaluate efficacy of anacetrapib (100 mg) on LDL-C, HDL-C, lipoprotein (a) [Lp(a)], non-HDL-C, apo-B, and apo A-I, compared to placebo.<br>2. To evaluate the efficacy of anacetrapib (100 mg) on plasma levels of total cholesterol (TC), triglycerides (TG), TC/HDL-C, LDL-C/HDL-C, apoB/apoA-I, and LDL-C/apoB, lipoprotein (a) [Lp(a)], hs-CRP, apoE, CETP activity and CETP mass, compared to placebo;Primary end point(s): LDL-C