Status:
COMPLETED
Cardioprotective Benefits of Carvedilol-CR or Valsartan Added to Lisinopril
Lead Sponsor:
State University of New York at Buffalo
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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
Detailed Description
Combination drug therapy is necessary for optimal blood pressure reduction and current guidelines mandate the concomitant use of ACE inhibitors and β-blockers in most patients at significant risk for ...
Eligibility Criteria
Inclusion
- Subjects with residual (uncontrolled) hypertension on lisinopril monotherapy, defined as 24-hour ambulatory diastolic BP \>85 mmHg.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00657241
Start Date
April 1 2008
End Date
April 1 2010
Last Update
May 27 2022
Active Locations (1)
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1
Erie County Medical Center
Buffalo, New York, United States, 14215