Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01863225




Registration number
NCT01863225
Ethics application status
Date submitted
16/05/2013
Date registered
27/05/2013
Date last updated
12/05/2015

Titles & IDs
Public title
Characterization of Multi-dose RVX000222 in Combination With Statin Treatment in Dyslipidemia
Scientific title
A Phase 2 Multiple-Dose Study to Characterize the Pharmacokinetics of RVX000222 Capsule Formulation in Combination With Either Atorvastatin or Rosuvastatin in Patients With Dyslipidemia
Secondary ID [1] 0 0
RVX222-CS-009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyslipidemia 0 0
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RVX000222
Treatment: Drugs - Rosuvastatin
Treatment: Drugs - Atorvastatin
Treatment: Drugs - Rosuvastatin
Treatment: Drugs - Atorvastatin

Experimental: Group A - RVX000222 200 mg (100 mg b.i.d.) + Atorvastatin 40 mg

Experimental: Group B - RVX000222 200 mg (100 mg b.i.d.) + Rosuvastatin 20 mg

Experimental: Group C - RVX000222 200 mg (100 mg b.i.d.) + Atorvastatin 80 mg

Experimental: Group D - RVX000222 200 mg (100 mg b.i.d.) + Rosuvastatin 40 mg


Treatment: Drugs: RVX000222
capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 14-days

Treatment: Drugs: Rosuvastatin
20 mg daily, 28-42 days

Treatment: Drugs: Atorvastatin
40 mg daily, 28-42 days

Treatment: Drugs: Rosuvastatin
40 mg daily, 28-42 days

Treatment: Drugs: Atorvastatin
80 mg daily, 28-42 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Characterization of the pharmacokinetics of RVX000222 capsule formulation in combination with either atorvastatin or rosuvastatin in patients with dyslipidemia.
Timepoint [1] 0 0
14 days
Secondary outcome [1] 0 0
Characterization of the pharmacokinetics of atorvastatin and rosuvastatin when either is administered in combination with RVX000222 capsule formulation to patients with dyslipidemia.
Timepoint [1] 0 0
14 days
Secondary outcome [2] 0 0
Evaluation of safety and tolerability of RVX000222 capsule formulation administered in combination with stable doses of either atorvastatin or rosuvastatin in patients with dyslipidemia.
Timepoint [2] 0 0
14

Eligibility
Key inclusion criteria
* Male and female patients = 18 to = 65 years of age with or without documented coronary artery disease.
* Taking statin therapy for at least 30 days prior to Screening (Visit 1).
* In the opinion of the investigator, patient currently on statin therapy other than atorvastatin 40 mg or rosuvastatin 20 mg or atorvastatin 80 mg or rosuvastatin 40 mg who could be switched to one of these regimens at Visit 1 for the duration of the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Clinically significant heart disease which will require coronary bypass, PCI, cardiac transplantation, surgical repair and/or replacement during the course of the study.
* Coronary artery bypass graft (CABG) procedure within the past 90 days.
* Have a body mass index (BMI) greater than 36 kg/m2.
* Patients of East Asian descent (due to pharmacological food effect noted for rosuvastatin).
* Previous or current diagnosis of severe heart failure (NYHA Class III-IV) or a documented left ventricular ejection fraction (LVEF) of < 25% as determined by contrast left ventriculography, radionuclide ventriculography or echocardiography. The absence of an LVEF measurement in a patient without a previous or current diagnosis of heart failure does not prohibit entry into the study.
* Patients with evidence of cardiac electrophysiologic instability including a history of uncontrolled ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response heart rate of > 100 beats per minute at rest within 4 weeks prior to Visit 1.
* Evidence of renal impairment
* Have hypertension that is uncontrolled defined as 2 consecutive measurements of sitting blood pressure of systolic >160 mmHg or diastolic > 95 mmHg at Visit 1.
* Women of child-bearing potential who do not agree to use two reliable methods of birth control during the study and for one month following the last dose of study drug, or pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive ß-hCG laboratory test (= 5 IU/L) at the time of enrollment. Where women of child-bearing potential are defined as women not surgically sterilized and between menarche and 1 year post menopause, and a reliable method of birth control includes use of oral contraceptives or levonorgestrel; or a reliable barrier method of birth control (diaphragms; cervical caps; condoms; intrauterine devices; partner with vasectomy; or abstinence).
* Current or recent (within 12 month prior to Visit 1) treatment with immunosuppressants (e.g., Cyclosporine).
* Triglycerides > 4.5 mmol/L at screening Visit 1.
* Use of fibrates of any dose or niacin/nicotinic acid 250 mg or more within 90 days prior to Visit 1
* 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, ulcerative colitis, or any gastric bypass alteration.
* Evidence of hepatic disease
* A total bilirubin that is > ULN by local laboratory at screening, Visit 1
* History of malignancy of any organ system, treated or untreated, within the past 5 years of Visit 1 whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
* History or evidence of drug or alcohol abuse within 12 months of Visit 1.
* Current dependence on nicotine containing products.
* 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.
* Use of any HIV and/or chemotherapy drugs, and/or antibiotics within 30 days or 5 half-lives of Visit 2, whichever is longer.
* Use of other investigational drugs and devices at the time of enrollment, or within 30 days or 5 half-lives of Visit 2, whichever is longer.
* History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
* Any condition that in the opinion of the investigator would confound the evaluation and interpretation of efficacy and/or safety data.
* Persons directly involved in the execution of this protocol.

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital / CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Resverlogix Corp
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
South Australian Health and Medical Research Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dr. Sepehr Shakib
Address 0 0
Royal Adelaide Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01863225