A Clinical Study of Ranolazine in Type 2 Diabetic Subjects with Chronic Stable Angina and Heart Disease

Phase 1

• Conditions: Angina; MedDRA version: 14.0Level: LLTClassification code 10049194Term: Stable angina pectorisSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-002273-29-SK
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-27
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1. Written informed consent
2. Males and females aged at least 18 years
3. At least a 3 month history of chronic stable angina triggered by physical effort and relieved by rest and/or sublingual nitroglycerin
4. Coronary artery disease (CAD) documented by one or more of the following:
(i) Angiographic evidence of = 50% stenosis of one or more major coronary arteries
(ii) History of myocardial infarction documented by positive CK-MB enzymes, troponins, or ECG changes
(iii) Cardiac imaging study or exercise treadmill test diagnostic for CAD
5. Treatment with up to 2 antianginal therapies at a stable dose for at least 2 weeks prior to the 4-week single-blind placebo run-in period. Allowed antianginals are the following: (i) beta-blocker (except sotalol), (ii) CCB (either dihydropyridine or non-dihydropyridine) (iv) LAN
6. Documented history of T2DM
7. Willing to maintain stable tobacco usage habits throughout the study
8. Willing to maintain stable activity levels throughout the study
9. Females of childbearing potential must agree to utilize highly effective contraception methods from Screening throughout the duration of study treatment and for 14 days following the last dose of study drug.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450

Exclusion Criteria

1. NYHA Class III and IV
2. Acute coronary syndrome in the prior 2 months or planned coronary revascularization during the study period
3. Stroke or transient ischemic attack within 6 months prior to Screening
4. QTc > 0.5 second
5. Uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg)
6. Systolic blood pressure < 100 mmHg
7. Clinically significant hepatic impairment
8. Prior treatment with ranolazine, or known hypersensitivity or intolerance to ranolazine
9. Females who have positive serum pregnancy test
10. Females who are breastfeeding
11. Participation in another investigational drug or device study within 1 month prior to Screening
12. Current treatment with trimetazidine, ivabradine, or nicorandil. Subjects will need to discontinue these medications 2 weeks prior to initiating the 4-week single-blind, placebo run-in period.
13. Current treatment with potent inhibitors of CYP3A (eg, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)
14. Current treatment with CYP3A and Pgp inducers (eg, rifampicin/rifampin, carbamazepine, and St. John’s wort)
15. Current treatment with CYP3A4 substrates with a narrow therapeutic range (eg, cyclosporine, tacrolimus, and sirolimus)
16. Subjects taking simvastatin who cannot reduce the dose to 20 mg once daily or who cannot switch to another statin
17. Current treatment with Class I or III antiarrhythmic medications
18. History of illicit drug use or alcohol abuse within 1 year of Screening
19. Any other conditions that, in the opinion of the investigator, are likely to prevent compliance with the study protocol or pose a safety concern if the subject participates in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified