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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: November 15, 2006
Last updated: July 27, 2016
Last verified: July 2016
This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (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 (RO4607381) Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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

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) ]
  • Potential changes in mesenteric lymph nodes [ Time Frame: Throughout study ]

Secondary Outcome Measures:
  • Change from baseline in high density lipoprotein cholesterol (HDL-C), total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1) [ Time Frame: Week 24 (Week 48 from start of NC19453) ]
  • Adverse events (AEs), laboratory parameters, vital signs [ Time Frame: Throughout study ]

Enrollment: 77
Study Start Date: January 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dalcetrapib (RO4607381) Drug: dalcetrapib (RO4607381)
900mg po daily for 24 weeks
Placebo Comparator: placebo Drug: placebo
po daily for 24 weeks


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00400439

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
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT00400439     History of Changes
Other Study ID Numbers: NC20716
Study First Received: November 15, 2006
Last Updated: July 27, 2016

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents processed this record on August 22, 2017