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A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
dalcetrapib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • CHD or CHD risk equivalent;
  • appropriately treated for accepted LDL-C level.

Exclusion Criteria:

  • 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dalcetrapib

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in % Flow Mediated Dilatation (FMD)
Change From Baseline in Mean BP, Measured by BP Monitoring

Secondary Outcome Measures

Change From Baseline in % FMD
Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB
CETP Activity
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
Change From Baseline in Mean BP, Measured by BP Monitoring
Percent Change CETP Mass

Full Information

First Posted
March 28, 2008
Last Updated
December 13, 2019
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00655538
Brief Title
A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
476 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dalcetrapib
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
po daily for 36 weeks
Intervention Type
Drug
Intervention Name(s)
dalcetrapib
Intervention Description
600mg po daily for 36 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in % Flow Mediated Dilatation (FMD)
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Mean BP, Measured by BP Monitoring
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in % FMD
Time Frame
baseline and 36 weeks
Title
Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB
Time Frame
Baseline to 36 weeks
Title
CETP Activity
Time Frame
Up to 36 weeks
Title
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
Time Frame
Baseline and 36 weeks
Title
Change From Baseline in Mean BP, Measured by BP Monitoring
Time Frame
Up to 36 weeks
Title
Percent Change CETP Mass
Time Frame
baseline to 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients, 18-75 years of age; CHD or CHD risk equivalent; appropriately treated for accepted LDL-C level. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Feldkirch
ZIP/Postal Code
6800
Country
Austria
City
Paris
ZIP/Postal Code
75908
Country
France
City
Bonn
ZIP/Postal Code
53127
Country
Germany
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Wuppertal
ZIP/Postal Code
42117
Country
Germany
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56100
Country
Italy
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
City
Breda
ZIP/Postal Code
4811 SW
Country
Netherlands
City
Eindhoven
ZIP/Postal Code
5611 NJ
Country
Netherlands
City
Goes
ZIP/Postal Code
4462 RA
Country
Netherlands
City
Groningen
ZIP/Postal Code
9711 SG
Country
Netherlands
City
Hoorn
ZIP/Postal Code
1625 HV
Country
Netherlands
City
Leiderdorp
ZIP/Postal Code
2352 RA
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
6525 EC
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3021 HC
Country
Netherlands
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
City
Velp
ZIP/Postal Code
6883 ES
Country
Netherlands
City
Zoetermeer
ZIP/Postal Code
2724 EK
Country
Netherlands
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22345126
Citation
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.
Results Reference
derived
PubMed Identifier
21128879
Citation
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.
Results Reference
derived

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A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients

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