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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 May 2014 |
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Main ID: |
EUCTR2010-022529-14-CZ |
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Date of registration:
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23/12/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A phase III, double-blind, randomized, placebo-controlled, multi-center study evaluating the efficacy and safety of dalcetrapib on lipids, lipoproteins, apolipoproteins and markers of CV risk in patients hospitalized for an acute coronary syndrome (ACS) when treatment is initiated within 1 week after an ACS (dal-ACUTE). - dal-ACUTE
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Scientific title:
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A phase III, double-blind, randomized, placebo-controlled, multi-center study evaluating the efficacy and safety of dalcetrapib on lipids, lipoproteins, apolipoproteins and markers of CV risk in patients hospitalized for an acute coronary syndrome (ACS) when treatment is initiated within 1 week after an ACS (dal-ACUTE). - dal-ACUTE |
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Date of first enrolment:
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04/02/2011 |
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Target sample size:
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300 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022529-14 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Czech Republic
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Netherlands
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Adult patients, >/=45 years of age
- Patients admitted to the hospital for acute coronary syndrome (ACS), defined as the occurence of: spontaneous myocardial infarction; hospitalization for ACS (Electrocardiogram abnormalities without biomarkers elevation)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- Women who are pregnant or breastfeeding
- Women of childbearing potential who are not using a highly effective contraceptive method at randomization
- Patients who have symptomatic congestive heart failure ([CHF], New York Heart Association [NYHA] Class III or IV)
- Clinically significant heart disease which is anticipated to require coronary artery bypass grafting (CBAG), cardiac transplantation, surgical repair and/or replacement of valves during the double-blind treatment phase of the study
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Coronary Heart Disease
MedDRA version: 14.0
Level: LLT
Classification code 10068617
Term: Coronary heart disease
System Organ Class: 10007541 - Cardiac disorders
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Intervention(s)
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Product Name: Dalcetrapib
Product Code: RO4607381
Pharmaceutical Form: Tablet
INN or Proposed INN: Dalcetrapib
CAS Number: 211513-37-0
Current Sponsor code: RO4607381
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): Primary efficacy endpoint:
Percent change from baseline in HDL-C levels after 4 weeks of
treatment.
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Main Objective: -To evaluate the effect of dalcetrapib on high-density lipoprotein C (HDL-C) levels after 4 weeks of treatment when treatment is initiated within one week after an ACS.
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Secondary Objective: -Similarity in percent change from baseline in high-density lipoprotein C (HDL-C) levels after 4 weeks of treatment in studies WC25501 and NC20971.
- Percent change of high-density lipoprotein C (HDL-C) treatment levels after 8, 12 and 20 weeks of treatment
- Percent change from baseline in blood lipid levels
- Percent change from baseline in Lipoprotein levels
- Percent change from baseline in Apolipoprotein levels
- Incidence of adverse events, timeframe: 24 weeks
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Source(s) of Monetary Support
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Results
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Results available:
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Date Completed:
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