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


Tracking Information

Start Date  ICMJEApril 2008
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2008)		Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00658515 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: April 10, 2008)
  • Composite endpoint:all cause mortality [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • Change from baseline in blood lipids and lipoprotein levels [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Adverse events, lab parameters, vital signs, ECG [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome
Official Title  ICMJEA 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
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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJECoronary Heart Disease
Intervention  ICMJE
  • Drug: RO4607381
    600mg po daily
  • Drug: Placebo
    po daily
  • Drug: Evidence-based medical care for Acute Coronary Syndrome
    As prescribed
Study Arms / Comparison Groups
  • 1: Experimental
    Interventions:
    • Drug: RO4607381
    • Drug: Evidence-based medical care for Acute Coronary Syndrome
  • 2: Placebo Comparator
    Interventions:
    • Drug: Placebo
    • Drug: Evidence-based medical care for Acute Coronary Syndrome
Publications *

Recruitment Information

Estimated Enrollment  ICMJE15600
Estimated Completion DateApril 2013
Primary Completion Date 
Eligibility Criteria  ICMJE

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).
GenderBoth
Ages45 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: NC20971888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   Ireland,   Israel,   Italy,   Korea, Republic of,   Netherlands,   New Zealand,   Poland,   Puerto Rico,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00658515
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJENC20971, 2007-005103-18
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche