Clinical trial NCT00655538: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Heart Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-04-10
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in % Flow Mediated Dilatation (FMD)
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean BP, Measured by BP Monitoring
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change From Baseline in % FMD
timeFrame: baseline and 36 weeks
measure: Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB
timeFrame: Baseline to 36 weeks
measure: CETP Activity
timeFrame: Up to 36 weeks
measure: 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
timeFrame: Baseline and 36 weeks
measure: Change From Baseline in Mean BP, Measured by BP Monitoring
timeFrame: Up to 36 weeks
measure: Percent Change CETP Mass
timeFrame: baseline to 36 weeks
Other outcomes:
Locations:
city: Feldkirch
country: Austria
city: Paris
country: France
city: Bonn
country: Germany
city: Dortmund
country: Germany
city: Frankfurt
country: Germany
city: Mainz
country: Germany
city: Wuppertal
country: Germany
city: Pisa
country: Italy
state: Toscana
city: Amsterdam
country: Netherlands
city: Breda
country: Netherlands
city: Eindhoven
country: Netherlands
city: Goes
country: Netherlands
city: Groningen
country: Netherlands
city: Hoorn
country: Netherlands
city: Leiderdorp
country: Netherlands
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Utrecht
country: Netherlands
city: Velp
country: Netherlands
city: Zoetermeer
country: Netherlands
city: Lugano
country: Switzerland
city: Zürich
country: Switzerland
city: Cardiff
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.
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.