A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients
NCT ID: NCT00655538
Last Updated: 2020-01-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
476 participants
INTERVENTIONAL
2008-02-29
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dalcetrapib
dalcetrapib
600mg po daily for 36 weeks
Placebo
Placebo
po daily for 36 weeks
Interventions
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Placebo
po daily for 36 weeks
dalcetrapib
600mg po daily for 36 weeks
Eligibility Criteria
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Inclusion Criteria
* CHD or CHD risk equivalent;
* appropriately treated for accepted LDL-C level.
Exclusion Criteria
* uncontrolled hypertension;
* recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
* severe anemia;
* poorly controlled diabetes.
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Feldkirch, , Austria
Paris, , France
Bonn, , Germany
Dortmund, , Germany
Frankfurt, , Germany
Mainz, , Germany
Wuppertal, , Germany
Pisa, Tuscany, Italy
Amsterdam, , Netherlands
Breda, , Netherlands
Eindhoven, , Netherlands
Goes, , Netherlands
Groningen, , Netherlands
Hoorn, , Netherlands
Leiderdorp, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Utrecht, , Netherlands
Velp, , Netherlands
Zoetermeer, , Netherlands
Lugano, , Switzerland
Zurich, , Switzerland
Cardiff, , United Kingdom
Countries
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References
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Luscher TF, Taddei S, Kaski JC, Jukema JW, Kallend D, Munzel T, Kastelein JJ, Deanfield JE; dal-VESSEL Investigators. Vascular effects and safety of dalcetrapib in patients with or at risk of coronary heart disease: the dal-VESSEL randomized clinical trial. Eur Heart J. 2012 Apr;33(7):857-65. doi: 10.1093/eurheartj/ehs019. Epub 2012 Feb 16.
Kastelein JJ, Duivenvoorden R, Deanfield J, de Groot E, Jukema JW, Kaski JC, Munzel T, Taddei S, Lehnert V, Burgess T, Kallend D, Luscher TF. Rationale and design of dal-VESSEL: a study to assess the safety and efficacy of dalcetrapib on endothelial function using brachial artery flow-mediated vasodilatation. Curr Med Res Opin. 2011 Jan;27(1):141-50. doi: 10.1185/03007995.2010.536207. Epub 2010 Dec 6.
Other Identifiers
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2007-003406-10
Identifier Type: -
Identifier Source: secondary_id
BC21144
Identifier Type: -
Identifier Source: org_study_id
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