A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients
A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.
2 other identifiers
interventional
476
7 countries
23
Brief Summary
This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2008
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
January 2, 2020
CompletedJanuary 2, 2020
December 1, 2019
2.2 years
March 28, 2008
July 17, 2019
December 13, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Change From Baseline in % Flow Mediated Dilatation (FMD)
Baseline and 12 weeks
Change From Baseline in Mean BP, Measured by BP Monitoring
Baseline and 4 weeks
Secondary Outcomes (6)
Change From Baseline in % FMD
baseline and 36 weeks
Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB
Baseline to 36 weeks
CETP Activity
Up to 36 weeks
Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9
Baseline and 36 weeks
Change From Baseline in Mean BP, Measured by BP Monitoring
Up to 36 weeks
- +1 more secondary outcomes
Study Arms (2)
Dalcetrapib
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- adult patients, 18-75 years of age;
- CHD or CHD risk equivalent;
- appropriately treated for accepted LDL-C level.
You may not qualify if:
- treatment with drugs raising HDL-C (eg niacin, fibrates);
- uncontrolled hypertension;
- recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
- severe anemia;
- poorly controlled diabetes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Unknown Facility
Feldkirch, 6800, Austria
Unknown Facility
Paris, 75908, France
Unknown Facility
Bonn, 53127, Germany
Unknown Facility
Dortmund, 44137, Germany
Unknown Facility
Frankfurt, 60596, Germany
Unknown Facility
Mainz, 55131, Germany
Unknown Facility
Wuppertal, 42117, Germany
Unknown Facility
Pisa, Tuscany, 56100, Italy
Unknown Facility
Amsterdam, 1105 AZ, Netherlands
Unknown Facility
Breda, 4811 SW, Netherlands
Unknown Facility
Eindhoven, 5611 NJ, Netherlands
Unknown Facility
Goes, 4462 RA, Netherlands
Unknown Facility
Groningen, 9711 SG, Netherlands
Unknown Facility
Hoorn, 1625 HV, Netherlands
Unknown Facility
Leiderdorp, 2352 RA, Netherlands
Unknown Facility
Nijmegen, 6525 EC, Netherlands
Unknown Facility
Rotterdam, 3021 HC, Netherlands
Unknown Facility
Utrecht, 3508 GA, Netherlands
Unknown Facility
Velp, 6883 ES, Netherlands
Unknown Facility
Zoetermeer, 2724 EK, Netherlands
Unknown Facility
Lugano, 6900, Switzerland
Unknown Facility
Zurich, 8091, Switzerland
Unknown Facility
Cardiff, CF14 4XN, United Kingdom
Related Publications (2)
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.
PMID: 22345126DERIVEDKastelein 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.
PMID: 21128879DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ryan Black
- Organization
- DalCor Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2008
First Posted
April 10, 2008
Study Start
February 1, 2008
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
January 2, 2020
Results First Posted
January 2, 2020
Record last verified: 2019-12