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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01516541




Registration number
NCT01516541
Ethics application status
Date submitted
13/01/2012
Date registered
25/01/2012
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease
Scientific title
A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients With Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD).
Secondary ID [1] 0 0
2011-001891-21
Secondary ID [2] 0 0
NC25608
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Background care
Treatment: Drugs - Placebo
Treatment: Drugs - dalcetrapib

Experimental: Dalcetrapib - Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care.

Placebo Comparator: Placebo - Placebo orally daily, on a background of contemporary, guidelines-based medical care.


Other interventions: Background care
Guidelines-based medical care

Treatment: Drugs: Placebo
Matching dalcetrapib placebo orally daily

Treatment: Drugs: dalcetrapib
600 mg orally daily
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity)
Timepoint [1] 0 0
approximately 4 years
Secondary outcome [1] 0 0
All cause mortality
Timepoint [1] 0 0
approximately 4 years
Secondary outcome [2] 0 0
Safety: Incidence of adverse events
Timepoint [2] 0 0
approximately 4 years
Secondary outcome [3] 0 0
Change in blood lipid and lipoprotein levels
Timepoint [3] 0 0
from baseline to 12 months

Eligibility
Key inclusion criteria
- Adult patients, >/= 45 years of age

- Established cardiovascular disease A stable coronary disease B cerebrovascular disease
C peripheral artery disease

- Without established coronary disease D pharmacologically treated type 2 diabetes
mellitus and one or more risk factor(s) for cardiovascular disease E 3 or more risk
factors for cardiovascular disease

- Receiving evidence-based medical and dietary management of dyslipidemia
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Occurrence of myocardial infarction, hospitalization for unstable angina, stroke or
revascularization (coronary, carotid or peripheral) within three months prior to
randomization

- Uncontrolled hypertension

- Uncontrolled diabetes

- Concomitant treatment with any other drug raising HDL-C

- Previous treatment with compounds targeting cholesteryl ester transfer protein (CETP)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2012
Sample size
Target
Accrual to date
Final
2220
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
- Milton
Recruitment hospital [2] 0 0
- Geelong
Recruitment hospital [3] 0 0
- Joondalup
Recruitment postcode(s) [1] 0 0
4064 - Milton
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
6027 - Joondalup
Recruitment outside Australia
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United States of America
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Alabama
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California
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Reading

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will
evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in
patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated
risk for cardiovascular disease. Eligible patients will be randomized to receive either
dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary,
guidelines-based medical care. Anticipated time on study treatment is 4 years.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01516541
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT01516541