AtherosclerosisPhase 2ASSERTNCT01058018
Clinical Trial for Dose Finding and Safety of RVX000222 in Subjects With Stable Coronary Artery Disease
A Phase 2 study testing RVX000222 in people with Atherosclerosis and Coronary Artery Disease, run by Resverlogix Corp at 1 site in United States.
Trial summary
The purpose of this study is to investigate dose range, safety and efficacy of RVX000222 in subjects with stable coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Coronary Artery Disease
- What is being tested?
- RVX000222
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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?
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange County Research Center
Tustin, California, 92780
About this study
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
The purpose of this study is to investigate dose range, safety and efficacy of RVX000222 in subjects with stable coronary artery disease.
Read the 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.
- Conditions
- Atherosclerosis, Coronary Artery Disease
- Being tested
- RVX000222, Placebo
- Keywords
- Cholesterol, High density lipoprotein, Atherosclerosis, ApolipoproteinA1, Stable angina artery disease
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVX000222Drug
Also called RVX-208, apabetalone
RVX000222 twice a day for 12 weeks
PlaceboDrug
Placebo twice a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change in ApoA1 from baseline to 12 weeks post-randomization for each treatment arm compared to placebo.
Measured: 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.
Measured: 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resverlogix Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Nicholls, MD, PhD, Principal investigator, Intravascular Ultrasound Core Lab, Clevelend Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058018
- Sponsor's protocol ID
- RVX222-CS-005
- Acronym
- ASSERT
- Status last verified
- Mar 2023
- First submitted
- 26 Jan 2010
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21255957
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01058018
- Acronym / sponsor ID
- ASSERT / RVX222-CS-005
- Conditions
- Atherosclerosis, Coronary Artery Disease
- Keywords
- Cholesterol, High density lipoprotein, Atherosclerosis, ApolipoproteinA1, Stable angina artery disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Resverlogix CorpIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A - 100 mg per day RVX000222 | Experimental | Drug: RVX000222Arm 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. |
| B - 200 mg per day RVX000222 | Experimental | Drug: RVX000222Arm 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. |
| C - 300 mg per day RVX000222 | Experimental | Drug: RVX000222Arm 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. |
| D - Placebo | Placebo comparator | Drug: PlaceboArm D: Treatment with placebo for 12 weeks, orally with meals in the morning and in the evening, 10 to 12 hours apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (24 listed)
- 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:
- Currently taking any immunosuppressant's
- Any changes in stain therapy doses in last 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RVX000222Also: RVX-208, apabetaloneRVX000222 twice a day for 12 weeks | Drug | A - 100 mg per day RVX000222, B - 200 mg per day RVX000222, C - 300 mg per day RVX000222 |
| PlaceboPlacebo twice a day for 12 weeks | Drug | D - Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Derived from this study: PubMed 21255957Nicholls 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Nicholls, MD, PhD principal investigator
Intravascular Ultrasound Core Lab, Clevelend Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RVX000222 in people with Atherosclerosis and Coronary Artery Disease, run by Resverlogix Corp at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01058018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.