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

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.
 
ClinicalTrials.gov Identifier: NCT00658515
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: Dalcetrapib (RO4607381) Drug: Evidence-based medical care for Acute Coronary Syndrome Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15871 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : April 2008
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Dalcetrapib (RO4607381) Drug: Dalcetrapib (RO4607381)
600mg po daily

Drug: Evidence-based medical care for Acute Coronary Syndrome
As prescribed
Placebo Comparator: Placebo Drug: Evidence-based medical care for Acute Coronary Syndrome
As prescribed

Drug: Placebo
po daily


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Cardiovascular Mortality and Morbidity [ Time Frame: From date of randomization to first event up to 48 months ]
    Number of cardiovascular events per patient per year


Secondary Outcome Measures :
  1. Composite Endpoint:All Cause Mortality [ Time Frame: Throughout Study, up to 53 Months ]
  2. Change From Baseline for HDL Cholesterol [ Time Frame: At 53 Months ]
  3. Adverse Events, Lab Parameters, Vital Signs, ECG [ Time Frame: Throughout Study, up to 53 Months ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658515


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00658515    
Other Study ID Numbers: NC20971
2007-005103-18
First Posted: April 15, 2008    Key Record Dates
Results First Posted: January 3, 2020
Last Update Posted: January 3, 2020
Last Verified: December 2019
Additional relevant MeSH terms:
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Heart Diseases
Acute Coronary Syndrome
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Dalcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents