Back to results

Clinical Trial for Dose Finding and Safety of RVX000222 in Subjects With Stable Coronary Artery Disease (ASSERT)

Primary Purpose

Atherosclerosis, Coronary Artery Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

RVX000222

Placebo

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring Cholesterol, High density lipoprotein, Atherosclerosis, ApolipoproteinA1, Stable angina artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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?

Sites / Locations

Orange County Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

A - 100 mg per day RVX000222

B - 200 mg per day RVX000222

C - 300 mg per day RVX000222

D - Placebo

Arm Description

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.

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.

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.

Arm D: Treatment with placebo for 12 weeks, orally with meals in the morning and in the evening, 10 to 12 hours apart.

Outcomes

Primary Outcome Measures

The percent change in ApoA1 from baseline to 12 weeks post-randomization for each treatment arm compared to placebo.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01058018

First Posted

January 26, 2010

Last Updated

March 27, 2023

Sponsor

Resverlogix Corp

1. Study Identification

Unique Protocol Identification Number

NCT01058018

Brief Title

Clinical Trial for Dose Finding and Safety of RVX000222 in Subjects With Stable Coronary Artery Disease

Acronym

ASSERT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Resverlogix Corp

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to investigate dose range, safety and efficacy of RVX000222 in subjects with stable coronary artery disease.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis, Coronary Artery Disease

Keywords

Cholesterol, High density lipoprotein, Atherosclerosis, ApolipoproteinA1, Stable angina artery disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

299 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A - 100 mg per day RVX000222

Arm Type

Experimental

Arm Description

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.

Arm Title

B - 200 mg per day RVX000222

Arm Type

Experimental

Arm Description

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.

Arm Title

C - 300 mg per day RVX000222

Arm Type

Experimental

Arm Description

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.

Arm Title

D - Placebo

Arm Type

Placebo Comparator

Arm Description

Arm D: Treatment with placebo for 12 weeks, orally with meals in the morning and in the evening, 10 to 12 hours apart.

Intervention Type

Drug

Intervention Name(s)

RVX000222

Other Intervention Name(s)

RVX-208, apabetalone

Intervention Description

RVX000222 twice a day for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo twice a day for 12 weeks

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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?

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steve Nicholls, MD, PhD

Organizational Affiliation

Intravascular Ultrasound Core Lab, Clevelend Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Orange County Research Center

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21255957

Citation

Nicholls SJ, Gordon A, Johansson J, Wolski K, Ballantyne CM, Kastelein JJ, Taylor A, Borgman M, Nissen SE. Efficacy and safety of a novel oral inducer of apolipoprotein a-I synthesis in statin-treated patients with stable coronary artery disease a randomized controlled trial. J Am Coll Cardiol. 2011 Mar 1;57(9):1111-9. doi: 10.1016/j.jacc.2010.11.015. Epub 2011 Jan 20.

Results Reference

derived

Learn more about this trial

Clinical Trial for Dose Finding and Safety of RVX000222 in Subjects With Stable Coronary Artery Disease

We'll reach out to this number within 24 hrs