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CETP Inhibitor
Dalcetrapib for Heart Attack (dal-GenE-2 Trial)
Phase 3
Recruiting
Research Sponsored by DalCor Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
AA genotype at variant gene as determined by Genotype Assay Test, conducted at a designated investigational testing site (ITS)
Both male and female subjects age 45 years and over at screening visit (V1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up average of 30 months from randomization
Awards & highlights
dal-GenE-2 Trial Summary
This trial tests a drug to treat a genetic form of heart attack. Subjects with the right genetic profile will give consent, and will be tested and assessed for eligibility. Randomization must occur within 12 weeks of the heart attack.
Who is the study for?
This trial is for adults over 45 who've been hospitalized with Acute Coronary Syndrome (ACS) within the last 3 months, are stable, and have a specific AA genotype. They must be on LDL-C management and not pregnant or breastfeeding. Excluded are those with severe kidney/liver disease, uncontrolled hypertension, certain heart failures, recent other trials participation or life expectancy under 3 years.Check my eligibility
What is being tested?
The study tests Dalcetrapib's effect on cardiovascular risk in patients with a recent ACS event and a particular genetic profile. It's randomized (patients assigned by chance), double-blind (neither researchers nor participants know who gets what treatment), comparing Dalcetrapib against a placebo.See study design
What are the potential side effects?
While the side effects of Dalcetrapib aren't detailed here, similar medications often cause issues like nausea, muscle pain, increased liver enzymes or allergic reactions. The exact side effects will be monitored throughout the trial.
dal-GenE-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My genetic test shows I have the AA genotype.
Select...
I am 45 years old or older.
Select...
I haven't had chest pain or discomfort when resting or with light activity for at least a week.
dal-GenE-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ average of 30 months from randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~average of 30 months from randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to first occurrence of any fatal or non-fatal myocardial infarction (MI)
Secondary outcome measures
Composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke
Fatal and non-fatal MI
The composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke
Side effects data
From 2006 Phase 2 trial • 292 Patients • NCT006972031%
Neuropathy Peripheral
1%
Malaise
1%
Constipation
1%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dalcetrapib 600mg
Dalcetrapib 300mg
Dalcetrapib 900mg
Placebo
dal-GenE-2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DalcetrapibExperimental Treatment1 Intervention
Dalcetrapib 600 mg (two 300 mg tablets) orally once daily
Group II: PlaceboPlacebo Group1 Intervention
Matching dalcetrapib placebo tablets (2 tablets) orally once per day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dalcetrapib
2005
Completed Phase 2
~520
Find a Location
Who is running the clinical trial?
The Montreal Health Innovations Coordinating Center (MHICC)OTHER
13 Previous Clinical Trials
8,886 Total Patients Enrolled
1 Trials studying Acute Coronary Syndrome
6,147 Patients Enrolled for Acute Coronary Syndrome
DalCor PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
6,374 Total Patients Enrolled
1 Trials studying Acute Coronary Syndrome
6,147 Patients Enrolled for Acute Coronary Syndrome
David Kallend, MBBSStudy DirectorDalCor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My genetic test shows I have the AA genotype.I do not have any other major health issues that could affect the study.Your CPK levels have been very high for a long time without a clear reason in the past 6 months.I do not have significant liver problems like jaundice or very high liver enzyme levels.I had a heart attack or similar event less than 3 months ago.I am 45 years old or older.My blood pressure is very high despite taking medication for it.I have severe heart failure.My heart issue was likely caused by high blood pressure.I was hospitalized for acute coronary syndrome within the last 3 months and have the right genetic background.I haven't had chest pain or discomfort when resting or with light activity for at least a week.My kidney function test shows severe impairment.I am a woman who can have children and am not using effective birth control.I have been managing my LDL cholesterol through diet and medication as per guidelines.I am not pregnant or breastfeeding.I have had heart bypass surgery recently.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Dalcetrapib
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what geographical locations is this investigation being conducted?
"Currently, 60 clinical trial sites are actively recruiting patients for this medical study. Patients may select the site closest to them in order to minimise travel-related burdens; options span from Huntsville and Mobile through Torrance and beyond."
Answered by AI
Are researchers currently recruiting participants for this experiment?
"According to the clinicaltrials.gov page, this medical study has ended recruitment and is no longer open for enrollment. Initially posted on June 1st of 2023 and last updated on 15th of that same month, this trial may have concluded but there are still 1474 other studies seeking patient participation at present time."
Answered by AI
What have been the observed effects of administering Dalcetrapib to patients?
"Considering the efficacy and safety data collected in Phase 3 trials, Dalcetrapib has been judged to be a safe medication with an overall score of 3."
Answered by AI
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