A Phase IIB, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study, Evaluating the Safety, Tolerability and Efficacy of RO4607381 by Measuring Flow Mediated Dilatation in the Brachial Artery, 24 hour Ambulatory Blood Pressure, Lipids, Lipoproteins and Markers Vascular Inflammation, Oxidation and CV risk in Patients with Coronary Heart Disease (CHD) or CHD Risk Equivalents - ND
- Conditions
- Improved vascular function with RO4607381 compared to placebo in patients with CHD or CHD risk equivalent who are treated with lipid lowering drugs to an acceptable LDL-C level.MedDRA version: 9.1Level: HLGTClassification code 10013317Term: Lipid metabolism disorders
- Registration Number
- EUCTR2007-003406-10-IT
- Lead Sponsor
- ROCHE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
Both male and female patients able and willing to provide written informed consent Age 18-75 years (inclusive) at visit 1 Signed informed consent (approved by Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures Patients with CHD or CHD risk equivalent based on NCEP ATPIII, eg. atherosclerosis, diabetes or >20% 10 year risk of CHD events HDL-C <50 mg/dL (<1.3 mmol/L) at visit 1 Triglycerides level ≤ 400 mg/dL (<4.5 mmol/L) at visit 1 Appropriately treated with statin and/or other LDL lowering drug to a stable accepted LDL level (<100 mg/dL [<2.6 mmol/L] unless taking maximimum tolerated doses of therapy) based on their medical condition
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
Females who are pregnant or breast feeding Women of child bearing potential (women who are not surgically sterile or post-menopausal defined as amenorrhea for > 12 months or amenorrhea for 6 ? 12 months and FSH ≥ 45U/L) Concomitant treatment with niacin, fibrates, bile acid sequestrants, rimonabant or CETP therapy. Treatment with ezetimibe and fish oil derivatives will be permitted. Concomitant treatment with any drug other than RO4607381 administered for the purpose of increasing levels of HDL-C. Patients with clinically apparent liver disease, eg, jaundice, choleastasis, hepatic synthetic impairment, or active hepatitis Hepatic transaminase, alkaline phosphatase or total bilirubin levels >1.5 times the ULN at Visit 1 Unexplained creatine phosphokinase levels >3 times the ULN at visit 1 Uncontrolled blood pressure: Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening or any other prerandomization visit Serum creatinine > 2.2 mg/dL at Visit 1. Recent (within 3 months before Visit 1) clinically significant coronary events, including unstable angina, myocardial infarction, angioplasty, or coronary artery bypass graft. Recent (within 3 months before Visit 1) transient ischemic attacks or cerebrovascular accident Poorly controlled diabetes mellitus (HbA1c >10%) due to inability to comply with recommended diabetes management Severe anemia defined as hemoglobin (Hb)< 10g/dL Patients with homozygous familial hypercholesterolemia Current or history of drug or alcohol abuse within 5 years of Visit 1 History of malignancy (except for curatively treated basal cell or squamous cell carcinoma of the skin) during the 3 years prior to Visit 1 Any clinically significant medical condition that could interfere with the conduct of the study Presence of any abnormality on a laboratory evaluation performed prior to randomization that is considered by the investigator to be clinically important. History of receiving R04607381 in a clinical trial in the previous 12 months Subjects previously exposed to torcetrapib Use of any investigational drug within 1 month before Visit 1 Subjects who have received an investigational drug or device within 1 month of visit 1, or who expect to participate in any other investigational drug or device study during the conduct of this trial Inability or unwillingness to comply with the protocol requirements, or deemed by the investigator to be unfit for the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method