DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Study on the Effects of Ranolazine on Exercise Duration in Subjects With Chronic Stable Angina and Coronary Artery Disease (CAD) With Type 2 Diabetes Mellitus (T2DM)

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Angina Pectoris; Coronary Artery Disease; Type 2 Diabetes Mellitus

Intervention: Ranolazine (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Jay Garg, MD, Study Director, Affiliation: Gilead Sciences

Summary

This study will evaluate the efficacy of ranolazine compared to placebo on duration of exercise assessed by exercise tolerance testing (ETT) at anticipated peak ranolazine plasma concentration after 12 weeks of treatment in subjects with chronic stable angina and coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM).

Clinical Details

Official title: A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel Study of Ranolazine in Subjects With Chronic Stable Angina and Coronary Artery Disease With a History of Type 2 Diabetes Mellitus

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The primary efficacy endpoint is the change from baseline in exercise treadmill duration in the peak ETT at week 12 or last visit.

Secondary outcome:

Time to onset of angina during peak ETT at week 12 or last visit

Time to onset of 1 mm ST-segment depression during peak ETT at week 12 or last visit

Change from baseline in exercise treadmill duration in the trough ETT at week 12

Detailed description: This study will evaluate the efficacy of ranolazine compared to placebo on duration of exercise assessed by exercise tolerance testing (ETT) at anticipated peak ranolazine plasma concentration after 12 weeks of treatment in subjects with chronic stable angina and coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM). This is a randomized, double-blind, placebo-controlled, parallel group study in subjects with chronic stable angina and CAD receiving a stable dose of a single concomitant antianginal medication who also have a history of T2DM; allowed antianginals will be a beta-blocker (atenolol or metoprolol) or a calcium-channel blocker.

Eligibility

Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Written informed consent

- Males and females aged 18 to 79 years

- Able to perform a Sheffield Modified Bruce Treadmill Exercise Protocol

- At least a 3-months history of chronic stable angina triggered by physical effort and

relieved by rest and/or sublingual nitroglycerin

- Coronary artery disease documented by one or more of the following:

- Angiographic evidence of ≥ 50% stenosis of one or more major coronary arteries

- History of myocardial infarction (MI) documented by positive CK-MB enzymes,

troponins, or ECG changes

- Cardiac nuclear scan studies diagnostic of CAD, e. g., thallium scan or ECHO with

stress or pharmacologic interventions (adenosine, dipyridamole, etc.)

- Stable treatment with one of the following antianginal medications for at least 4

weeks prior to Screening:

- beta-blocker (atenolol up to 50 mg daily or metoprolol up to 100 mg daily)

- dihydropyridine calcium-channel blocker (amlodipine up to 5 mg daily or

nifedipine up to 30 mg daily)

- non-dihydropyridine calcium-channel blocker (diltiazem 180 to 360 mg daily or

verapamil 180 to 360 mg daily)

- Willingness to discontinue other antianginals and be treated with one of the allowed

antianginal therapies

- Documented history of type 2 diabetes mellitus

- 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. Exclusion Criteria:

- Inability to exercise or having exercise limitation due to other co-morbidities that

may interfere with ability to perform required ETT (e. g., morbid obesity, significant chronic lung disease, prior hospitalization for acute exacerbation of chronic lung disease or home oxygen use, chronic oral steroid therapy that can limit exercise capacity, osteoarthritis, peripheral artery disease, etc.)

- Any absolute contraindication to ETT

- Presence of electrocardiographic or other abnormalities that interfere with ECG

interpretation or may cause a false positive stress test (e. g., ≥ 1 mm horizontal or down-sloping ST segment depression at rest in any standard ECG lead, Lown-Ganong-Levine syndrome, Wolff-Parkinson-White syndrome, left bundle branch block, left ventricular hypertrophy with repolarization abnormality, ventricular pacemaker, etc.)

- Decompensated heart failure

- Clinically significant valvular heart disease or congenital cardiac defects

- Acute coronary syndrome in the prior 2 months or coronary revascularization within

the prior 6 months or planned coronary revascularization during the study period

- Stroke or transient ischemic attack within 6 months prior to Screening

- History of serious ventricular dysrhythmias or a history of life-threatening

ventricular arrhythmia

- Atrial fibrillation

- QTc > 0. 5 seconds

- Hypertrophic cardiomyopathy

- Uncontrolled hypertension (seated systolic blood pressure > 180 mm Hg or diastolic

blood pressure > 110 mm Hg)

- Systolic blood pressure < 90 mm Hg

- Inability to discontinue current antianginal medications and remain on one allowed

antianginal therapy

- Clinically significant hepatic impairment

- Creatinine clearance (CLCr) < 30 ml/min

- Prior treatment with ranolazine

- Participation in another investigational drug or device study within 1 month prior to

Screening

- Females who are breastfeeding

- Positive serum pregnancy test

- Current treatment with potent inhibitors of CYP3A (e. g., ketoconazole, itraconazole,

clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)

- Current treatment with CYP3A and P glycoprotein (Pgp) inducers (e. g.,

rifampicin/rifampin, carbamazepine, St. John's wort)

- History of illicit drug use or alcohol abuse within one year of screening

- 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

Locations and Contacts

Additional Information

Starting date: May 2011
Last updated: July 27, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017