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

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ClinicalTrials.gov Identifier: NCT00658515
Recruitment Status : Completed
First Posted : April 15, 2008
Last Update Posted : November 2, 2016
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 : 15865 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. Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) [ Time Frame: Event driven ]

Secondary Outcome Measures :
  1. Composite endpoint:all cause mortality [ Time Frame: Event driven ]
  2. Change from baseline in blood lipids and lipoprotein levels [ Time Frame: Throughout study ]
  3. Adverse events, lab parameters, vital signs, ECG [ Time Frame: Throughout study ]

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


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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00658515     History of Changes
Other Study ID Numbers: NC20971
2007-005103-18
First Posted: April 15, 2008    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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