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

NCT01058018 | Completed Phase 2 DMC

• 1 other identifier: RVX222-CS-005
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atherosclerosis; Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  from baseline to 12 weeks post-study drug treatment

Secondary Outcomes (1)

• 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.

  4, 8 and 12 weeks

Study Arms (4)

A - 100 mg per day RVX000222

EXPERIMENTAL

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.

Drug: RVX000222

B - 200 mg per day RVX000222

EXPERIMENTAL

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.

Drug: RVX000222

C - 300 mg per day RVX000222

EXPERIMENTAL

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.

Drug: RVX000222

D - Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

RVX000222 DRUG

RVX000222 twice a day for 12 weeks

Also known as: RVX-208, apabetalone

A - 100 mg per day RVX000222; B - 200 mg per day RVX000222; C - 300 mg per day RVX000222

Placebo DRUG

Placebo twice a day for 12 weeks

D - Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Resverlogix Corp: lead

Study Sites (1)

Orange County Research Center

Tustin, California, 92780, United States

Location

Related Publications (1)

• 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.

  PMID: 21255957 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease

Interventions

apabetalone

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Study Officials

• Steve Nicholls, MD, PhD

  Intravascular Ultrasound Core Lab, Clevelend Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 28, 2010
• Study Start: December 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

US (1)