CTRI/2015/01/005359CompletedPhase 3
A Multicentric, Prospective, Double blind, Randomized, Comparative Clinical trial to evaluate the Efficacy and Tolerability of Efonidipine in the treatment of Hypertension
Zuventus Healthcare Ltd12 sites in 1 country200 target enrollmentStarted: January 30, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Zuventus Healthcare Ltd
- Enrollment
- 200
- Locations
- 12
- Primary Endpoint
- •Proportion of patients achieving heart rate 83 beats per minute by the end of treatment (as per Framingham Heart Study)
Study Overview
Brief Summary
A Multicentric, Prospective, Double blind, Randomized,Comparative Clinical trial to evaluate the Efficacy and Tolerability of
Efonidipinein the treatment of Hypertension
The aim of the study is to establishnon-inferiority of Efonidipine hydrochloride when compared with Amlodipine inthe management of hypertension
Primary Objective
- To assess the efficacy of Efonidipine 40 mg given once a day orally in alleviating symptoms of hypertension
Secondary Objective
- To evaluate the safety & tolerability of the investigational drug in Indian patients.
- Toevaluate patient compliance
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Double Blind Double Dummy
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients aged 18 to 65 years 2.Patients with stage 1 hypertension as per Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC VII) 3.Patients with heart rate > 83 beats/min 4.Patients ready to sign informed consent.
Exclusion Criteria
- •1.Patients with severe hypertension with sitting systolic BP ≥ 180 mm Hg 2.Patients with history of stroke or myocardial infarction in the previous 6 months 3.Patients with congestive heart failure, sick sinus syndrome or sinus bradycardia (< 50 beats/min) 4.Patients with second- or third-degree atrioventricular block 5.Patients with documented hypersensitivity to dihydropyridine CCBs 6.Patients with hepatic disease with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper normal limit 7.Patients with renal disease with a serum creatinine concentration > 2.0 mg/dL 8.Patients with uncontrolled diabetes, (hemoglobin A1C > 9%), renal artery stenosis, or secondary hypertension 9.Pregnant women or nursing mothers 10.Females with child bearing potential (considerations relate to choice of contraception, planning for pregnancy and overall obstetric care during pregnancy) 11.Patients with history of alcohol dependence, alcohol abuse or drug abuse 12.Patients with history of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form) 13.Patients scheduled for surgery anytime during the study 14.Patient receiving some other drug during the study besides that in the protocol that could possibly alter the bio availability of the drug 15.The patient previously been participated in any other clinical trial within the last month.
Outcomes
Primary Outcomes
•Proportion of patients achieving heart rate 83 beats per minute by the end of treatment (as per Framingham Heart Study)
Time Frame: 28 Days
•Proportion of patients achieving JNC VII target BP of 140/90 mm Hg by the end of treatment
Time Frame: 28 Days
Secondary Outcomes
- •Proportion of patients achieving JNC VII target BP of 140/90 mm Hg after 2 weeks of therapy
- •Proportion of patients achieving heart rate 83 beats per minute after 2 weeks of therapy
- •Symptom relief: Defined as the absence of the clinical symptom of dyspnea and palpitations after 4 weeks of therapy
- Adverse events observed during the treatment period(28 Days)
Investigators
Study Sites (12)
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