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A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease

Primary Purpose

Coronary Heart Disease

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Dalcetrapib (RO4607381)

Placebo

Sponsored by

Hoffmann-La Roche

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, including patients with other CHD risk factors;
treated appropriately for dyslipidemia;
clinically stable.

Exclusion Criteria:

previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or vaccine;
recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
severe anemia;
uncontrolled hypertension;
poorly controlled diabetes.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dalcetrapib (RO4607381)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Mean Wall Thickness

Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.

Secondary Outcome Measures

Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance

Change From Baseline in Vessel MR Determined Plaque Anatomy

Blood Lipids,Lipoproteins

Biomarkers

CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure

Full Information

NCT ID

First Posted

March 28, 2008

Last Updated

December 16, 2019

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00655473

Brief Title

A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease

Official Title

A Randomized, Placebo-controlled Study of the Effect of RO4607381 on Progression or Regression of Atherosclerotic Plaque in Patients With Coronary Heart Disease (CHD) Including Patients With Other CHD Risk Factors

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 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 effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 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

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dalcetrapib (RO4607381)

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Dalcetrapib (RO4607381)

Intervention Description

600mg po daily for 24 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

po daily for 24 months

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Mean Wall Thickness

Time Frame

24 months

Title

Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance

Time Frame

6 months

Title

Change From Baseline in Vessel MR Determined Plaque Anatomy

Time Frame

Up to 24 months

Title

Blood Lipids,Lipoproteins

Time Frame

Throughout study

Title

Biomarkers

Time Frame

Up to 24 months

Title

CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure

Time Frame

Throughout study

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, including patients with other CHD risk factors; treated appropriately for dyslipidemia; clinically stable. Exclusion Criteria: previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or vaccine; recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident; severe anemia; uncontrolled hypertension; 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

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

City

Statesville

State/Province

North Carolina

ZIP/Postal Code

28677

Country

United States

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45227

Country

United States

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

City

Seattle

State/Province

Washington

ZIP/Postal Code

98108

Country

United States

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 1C8

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

24135322

Citation

Duivenvoorden R, Mani V, Woodward M, Kallend D, Suchankova G, Fuster V, Rudd JHF, Tawakol A, Farkouh ME, Fayad ZA. Relationship of serum inflammatory biomarkers with plaque inflammation assessed by FDG PET/CT: the dal-PLAQUE study. JACC Cardiovasc Imaging. 2013 Oct;6(10):1087-1094. doi: 10.1016/j.jcmg.2013.03.009.

Results Reference

derived

PubMed Identifier

23942908

Citation

Calcagno C, Ramachandran S, Izquierdo-Garcia D, Mani V, Millon A, Rosenbaum D, Tawakol A, Woodward M, Bucerius J, Moshier E, Godbold J, Kallend D, Farkouh ME, Fuster V, Rudd JH, Fayad ZA. The complementary roles of dynamic contrast-enhanced MRI and 18F-fluorodeoxyglucose PET/CT for imaging of carotid atherosclerosis. Eur J Nucl Med Mol Imaging. 2013 Dec;40(12):1884-93. doi: 10.1007/s00259-013-2518-4. Epub 2013 Aug 14.

Results Reference

derived

PubMed Identifier

21908036

Citation

Fayad ZA, Mani V, Woodward M, Kallend D, Abt M, Burgess T, Fuster V, Ballantyne CM, Stein EA, Tardif JC, Rudd JH, Farkouh ME, Tawakol A; dal-PLAQUE Investigators. Safety and efficacy of dalcetrapib on atherosclerotic disease using novel non-invasive multimodality imaging (dal-PLAQUE): a randomised clinical trial. Lancet. 2011 Oct 29;378(9802):1547-59. doi: 10.1016/S0140-6736(11)61383-4. Epub 2011 Sep 9.

Results Reference

derived

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A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease

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