A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome

Coronary Heart Disease Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658515
• Other study ID #: NC20971
• Secondary ID: 2007-005103-18
• Status: Completed
• Phase: Phase 3
• Start date: April 2008
• Est. completion date: September 2012

Study information

• Verified date: December 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15871
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=45 years of age;

• recently hospitalized for ACS;

• clinically stable;

• receiving evidence-based medical and dietary management of dyslipidemia.

Exclusion Criteria:

• uncontrolled diabetes;

• clinically unstable;

• severe anemia;

• uncontrolled hypertension;

• concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Dalcetrapib (RO4607381)
600mg po daily
• Evidence-based medical care for Acute Coronary Syndrome
As prescribed
• Placebo
po daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Denmark,  Finland,  France,  Germany,  Grenada,  Hungary,  Ireland,  Israel,  Italy,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Puerto Rico,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Cardiovascular Mortality and Morbidity	Number of cardiovascular events per patient per year	From date of randomization to first event up to 48 months
Secondary	Composite Endpoint:All Cause Mortality		Throughout Study, up to 53 Months
Secondary	Change From Baseline for HDL Cholesterol		At 53 Months
Secondary	Adverse Events, Lab Parameters, Vital Signs, ECG		Throughout Study, up to 53 Months