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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00658515
First Posted: April 15, 2008
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
March 28, 2008
April 15, 2008
November 2, 2016
April 2008
September 2012   (Final data collection date for primary outcome measure)
Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) [ Time Frame: Event driven ]
Same as current
Complete list of historical versions of study NCT00658515 on ClinicalTrials.gov Archive Site
  • Composite endpoint:all cause mortality [ Time Frame: Event driven ]
  • Change from baseline in blood lipids and lipoprotein levels [ Time Frame: Throughout study ]
  • Adverse events, lab parameters, vital signs, ECG [ Time Frame: Throughout study ]
Same as current
Not Provided
Not Provided
 
A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Coronary Heart Disease
  • Drug: Dalcetrapib (RO4607381)
    600mg po daily
  • Drug: Evidence-based medical care for Acute Coronary Syndrome
    As prescribed
  • Drug: Placebo
    po daily
  • Experimental: Dalcetrapib (RO4607381)
    Interventions:
    • Drug: Dalcetrapib (RO4607381)
    • Drug: Evidence-based medical care for Acute Coronary Syndrome
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Evidence-based medical care for Acute Coronary Syndrome
    • Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15865
September 2012
September 2012   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
45 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Czech Republic,   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,   United States
Mexico,   Romania,   Russian Federation
 
NCT00658515
NC20971
2007-005103-18
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP