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A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00400439
First received: November 15, 2006
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a CHD risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 100 individuals.


Condition Intervention Phase
Coronary Heart Disease
 Drug: dalcetrapib
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage and absolute change from baseline in HDL-C [ Time Frame: Week 24 (Week 48 from start of NC19453) ] [ Designated as safety issue: No ]
  • Potential changes in mesenteric lymph nodes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in HDL-C, TC, LDL-C, TG, ApoB and ApoAl [ Time Frame: Week 24 (Week 48 from start of NC19453) ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: January 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: dalcetrapib
900mg po daily for 24 weeks
Placebo Comparator: 2 Drug: Placebo
po daily for 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who have completed treatment on study NC19453.

Exclusion Criteria:

  • any significant lymph node abnormalities at the end of study NC19453.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400439

Locations
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Louisville, Kentucky, United States, 40213
United States, Maryland
Bethesda, Maryland, United States, 20817
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Statesville, North Carolina, United States, 28677
United States, Ohio
Cincinnati, Ohio, United States, 45212
Cincinnati, Ohio, United States, 45219
United States, Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00400439     History of Changes
Other Study ID Numbers: NC20716
Study First Received: November 15, 2006
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Dalcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013