Cardioprotective Benefits of Carvedilol-CR or Valsartan Added to Lisinopril

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

14-week single blind, double baseline, forced-titration, cross-over comparison of the cardiac benefits of Coreg CR compared to valsartan added to existing ACE inhibition

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York at Buffalo
• Collaborator: GlaxoSmithKline
• Treatments: Carvedilol; Lisinopril; Valsartan

Criteria

Inclusion Criteria:

• Subjects with residual (uncontrolled) hypertension on lisinopril monotherapy, defined as 24-hour ambulatory diastolic BP >85 mmHg.

Exclusion Criteria:

A subject meeting any of the following conditions will be excluded from the study:

• History of serious adverse effects with ACE inhibitor, Coreg, or valsartan

• Known or suspected causes of secondary hypertension (e.g., renovascular stenosis, primary hyperaldosteronism)

• Known ischemic heart disease requiring beta-blocker therapy (includes angina, prior transmural myocardial infarction, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty or stenting within 6 months prior to study entry).

• Heart failure (NYHA Functional Class II-IV)

• Obstructive valvular heart disease or obstructive hypertrophic cardiomyopathy

• Presence of clinically significant ventricular or supraventricular arrhythmias (e.g. atrial fibrillation/flutter), pre-excitation syndrome, second or third degree AV block, other conduction defects necessitating the implantation of a permanent cardiac pacemaker, or sick sinus syndrome.

• Chronic kidney disease (serum creatinine >2.5 within past 6 months)

• Uncontrolled diabetes mellitus (i.e., a fasting blood glucose >200 mg/dL [>11.1 mmol/L] or hemoglobin A1c > 10%

• History of alcohol or other drug abuse within 6 months prior to enrollment

• Concomitant treatment or probable need for treatment with prohibited medications. NSAIDs, diabetes medications and other chronic meds are permitted if continued throughout study without dosage change.

• Any other medical condition which renders the subject unable to complete the study or which would interfere with optimal participation in the study or produce a significant risk to the subject

• Those with persistent systolic BP elevations above 179 mmHg will be discontinued from the study as will those with any significant adverse effect of medication.

• Positive pregnancy test or failure to practice adequate contraception in women of child-bearing potential

• Bronchospastic asthma requiring chronic steroid or inhaler therapy

• Any women with child-bearing potential