A 76-week, Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Tolerability and Efficacy of Anacetrapib When Added to Ongoing Therapy With a Statin in Patients with Hypercholesterolemia or Mixed HyperlipidemiaUn Estudio Mundial, Multicéntrico, en Doble Ciego, Randomizado, Controlado con Placebo, de 76 Semanas de Duración para Evaluar la Tolerabilidad y Eficacia de Anacetrapib Al Ser Añadido a la Terapia En Curso Con una Estatina en Pacientes Con Hipercolesterolemia o Hiperlipidemia Mixta - Efficacy of Anacetrapib withStati

Phase 1

• Conditions: Hypercholesterolemia, mixed hyperlipidemiaHipercolesterolemia, hiperlipidemia mixta; MedDRA version: 9.1Level: LLTClassification code 10003601Term: Atherosclerosis

• Registration Number: EUCTR2007-005839-28-ES
• Lead Sponsor: Merck Sharp & Dohme de España, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-22
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

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

Inclusion Criteria

1. Patient is male or female and =18 and =80 years of age on day of signing informed consent.

2. Patient meets one of the following LDL-C criterion based on NCEP ATP III categorization of CHD risk:
•Patient is high risk (CHD/CHD risk equivalent including diabetes) with an LDL-C <100 mg/dL (2.59 mmol/L).
•Patient has multiple risk factors (=2 RF) with an LDL-C <130 mg/dL (3.37 mmol/L).
•Patient is low risk [0-1 RF) with LDL-C <160 mg/dL (4.14 mmol/L)]

3. Patient is treated with statin ± other lipid-modifying therapy and has the following HDL-C criterion:
•Patient is high risk (CHD/CHD risk equivalent including diabetes) with HDL-C <60 mg/dL (1.55 mmol/L), in males and females.
•Patient has moderate (=2 RF) or low risk or with HDL-C, (i.e. HDL-C <44 mg/dL (1.14 mmol/L) in males, or HDL-C <54 mg/dL (1.40 mmol/L) in females.

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 severe chronic heart failure defined by New York Heart Association (NYHA) Classes III or IV.
2. Patient has uncontrolled cardiac arrhythmias, MI, PCI, CABG, unstable angina, or stroke MI within 3 months prior to Visit 1.
3. LDL-C <50 mg/dL (1.29 mmol/L).
4. Patient has uncontrolled hypertension defined as follows:
•Sitting diastolic blood pressure =100 mmHg, or sitting systolic blood pressure =160 mm Hg (non-diabetic patients).
OR
•Sitting diastolic blood pressure =90 mmHg, or sitting systolic blood pressure =150 mm Hg (diabetic patients).

Study & Design

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