- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01058018
Clinical Trial for Dose Finding and Safety of RVX000222 in Subjects With Stable Coronary Artery Disease (ASSERT)
March 27, 2023 updated by: Resverlogix Corp
Phase II Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled Clinical Trial for Dose-finding and Safety Study of RVX000222 in Subjects With Stable Coronary Artery Disease
The purpose of this study is to investigate dose range, safety and efficacy of RVX000222 in subjects with stable coronary artery disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
One-third of the US population, almost 80 million adults, have cardiovascular disease and mortality associated with heart disease still remains as a leading cause of death around the world.
The major risk factors for cardiovascular disease associated with atherosclerosis is dyslipidemia, characterized by high levels of low density lipoprotein (LDL) and/or low levels of high density lipoprotein (HDL).
The widespread use of statins in patients at risk for cardiovascular disease has led to lower LDL levels but has had little effect on HDL levels.
HDL has a well established role in atherosclerosis and cardiovascular disease protection.
HDL mediates the removal of cholesterol from the atherosclerotic plaques for elimination from the body.
The cardioprotective component of HDL consists of apolipoprotein A1 (ApoA1).
Recent intervention studies with synthetic HDL particles and recombinant ApoA1 have shown that HDL has the capacity to reverse coronary atherosclerosis.
Increasing ApoA1 is likely to have a favorable effect on atherosclerotic plaque size and stability, and on cardiovascular diseases.
RVX000222 is a member of a novel class of small molecules that are candidates for the treatment of dyslipidemia by increasing plasma levels of HDL through increased ApoA1 transcription.
Study Type
Interventional
Enrollment (Actual)
299
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Tustin, California, United States, 92780
- Orange County Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women at least 18 years of age.
- If female, non-pregnant (as determined by a negative serum pregnancy test at Screening), non-lactating, and not of childbearing-potential or willing to practice acceptable form of birth control. If male, be willing to practice an acceptable form of birth control.
- Documented coronary artery disease such as stable angina, coronary artery bypass graft, myocardial infarction within the past 90 days, or a history of percutaneous coronary intervention greater than 90 days before randomization
- Taking a stable dose of statin therapy for at least 30 days prior to enrollment into the study with, in the investigators opinion, an unlikely need for statin dose adjustment during the course of the study.
- Have given signed informed consent to participate in this study
Exclusion Criteria:
- A female who is pregnant or lactating?
- Participated in any research study, or been on an investigational drug within the last 30 days?
Currently have any of the following Illnesses:
- Heart disease needing surgical repair
- Coronary Artery bypass surgery in the last 90 days
- PCI or Stent placement in the last 90 days
- Left Ventricular ejection fraction
- Evidence of cardiac electrophysiologic instability
- Renal Impairment
- Uncontrolled Hypertension 160/95 (2 consecutive Measurements)
- Triglycerides ≥ 400 mg/dl (at Screening)
- Liver: Total bilirubin > ULN, ALT/AST 1.5 > ULN at Screening
- History of Drug or Alcohol abuse in last 12 months
- History of Malignancy ≤ 5 years
- Currently taking any immunosuppressant's
- Any changes in stain therapy doses in last 30 days
- Use of Fibrates at any dose
- Use of Niacin ≥ 250 mg per day
- Have any medical or surgical condition which might significantly alter the absorption, distribution, metabolism or excretion of medication including but not limited to any of the following: cholecystitis, Crohn's disease or ulcerative colitis?
- Have any surgical or medical condition which in the opinion of the Investigator may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study?
- Using other investigational drugs and devices at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer?
- Have a history of noncompliance to medical regimens or unwillingness to comply with the study protocol?
- Have any condition that in the opinion of the investigator would confound the evaluation and interpretation of efficacy and/or safety data?
- Directly involved in the execution of this study?
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A - 100 mg per day RVX000222
Arm A: Treatment with RVX000222 at 50 mg twice daily for 12 weeks, orally with meals in the morning and in the evening, 10 to 12 hours apart.
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RVX000222 twice a day for 12 weeks
Other Names:
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Experimental: B - 200 mg per day RVX000222
Arm B: Treatment with RVX000222 100 mg twice daily for 12 weeks, orally with meals in the morning and in the evening, 10 to 12 hours apart.
|
RVX000222 twice a day for 12 weeks
Other Names:
|
Experimental: C - 300 mg per day RVX000222
Arm C: Treatment with RVX000222 150 mg twice daily for 12 weeks, orally with meals in the morning and in the evening, 10 to 12 hours apart.
|
RVX000222 twice a day for 12 weeks
Other Names:
|
Placebo Comparator: D - Placebo
Arm D: Treatment with placebo for 12 weeks, orally with meals in the morning and in the evening, 10 to 12 hours apart.
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Placebo twice a day for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The percent change in ApoA1 from baseline to 12 weeks post-randomization for each treatment arm compared to placebo.
Time Frame: from baseline to 12 weeks post-study drug treatment
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from baseline to 12 weeks post-study drug treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare the dose and time response relationships for major lipids (ApoA1, total cholesterol, HDL-C, LDL-C, non-HDL-C, TG, ApoB, LDL, and HDL-subclasses) over 4, 8 and 12 weeks time course.
Time Frame: 4, 8 and 12 weeks
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4, 8 and 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
January 26, 2010
First Submitted That Met QC Criteria
January 27, 2010
First Posted (Estimate)
January 28, 2010
Study Record Updates
Last Update Posted (Actual)
April 3, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RVX222-CS-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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