NCT00353522

Brief Summary

This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2006

Geographic Reach
2 countries

17 active sites

Status
completed

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

July 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
11.3 years until next milestone

Results Posted

Study results publicly available

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2.3 years

First QC Date

July 17, 2006

Results QC Date

July 17, 2019

Last Update Submit

January 24, 2020

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (2)

  • Absolute Change From Baseline in HDL-C

    Baseline and Week 24

  • Percent Change From Baseline in HDL-C

    Baseline and Week 24

Secondary Outcomes (4)

  • Percent Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Mass

    Baseline and Weeks 24

  • Change in Mesenteric Lymph Nodes

    Baseline and 48 Weeks

  • Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)

    Baseline and 48 Weeks

  • Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Activity

    Baseline and 48 Weeks

Study Arms (2)

Dalcetrapib

EXPERIMENTAL

Dalcetrapib 900mg po daily for 24 weeks

Drug: dalcetrapib

Placebo

PLACEBO COMPARATOR

Placebo po daily for 24 weeks

Drug: Placebo

Interventions

PlaceboDRUG

po daily for 24 weeks

Placebo
dalcetrapibDRUG

900mg po daily for 24 weeks

Dalcetrapib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, 18-75 years of age;
  • CHD or CHD risk equivalent;
  • body weight \<125kg at visit 1.

You may not qualify if:

  • recent (within 3 weeks of screening) clinically significant coronary events;
  • history of statin-associated myopathy, or intolerance to statin;
  • history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening;
  • exposure to RO4607381 in past 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Chicago, Illinois, 60610, United States

Location

Unknown Facility

Indianapolis, Indiana, 46260, United States

Location

Unknown Facility

Iowa City, Iowa, 52242, United States

Location

Unknown Facility

Louisville, Kentucky, 40213, United States

Location

Unknown Facility

Bethesda, Maryland, 20817, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55455, United States

Location

Unknown Facility

Statesville, North Carolina, 28677, United States

Location

Unknown Facility

Cincinnati, Ohio, 45212, United States

Location

Unknown Facility

Cincinnati, Ohio, 45219, United States

Location

Unknown Facility

Salt Lake City, Utah, 84132, United States

Location

Unknown Facility

Berlin, 10707, Germany

Location

Unknown Facility

Bochum, 06097, Germany

Location

Unknown Facility

Dortmund, 44137, Germany

Location

Unknown Facility

Erlangen, 91054, Germany

Location

Unknown Facility

Freiburg im Breisgau, 79106, Germany

Location

Unknown Facility

Hamburg, 20249, Germany

Location

Unknown Facility

München, 80336, Germany

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

dalcetrapib

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Results Point of Contact

Title
Ryan Black
Organization
DalCor Pharmaceuticals
rblack@dalcorpharma.com

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

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

July 17, 2006

First Posted

July 18, 2006

Study Start

July 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

January 27, 2020

Results First Posted

January 27, 2020

Record last verified: 2020-01

Locations

DE(7)US(10)