Clinical trial to evaluate the Efficacy and Tolerability of Efonidipine in the treatment of Hypertensio
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2015/01/005359
- Lead Sponsor
- Zuventus Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Proportion of patients achieving JNC VII target BP of 140/90 mm Hg by the end of treatment <br/ ><br>â?¢Proportion of patients achieving heart rate 83 beats per minute by the end of treatment (as per Framingham Heart Study) <br/ ><br>Timepoint: 28 Days
- Secondary Outcome Measures
Name Time Method Adverse events observed during the treatment periodTimepoint: 28 Days;â?¢Proportion of patients achieving heart rate 83 beats per minute after 2 weeks of therapy <br/ ><br>Timepoint: 28 Days;â?¢Proportion of patients achieving JNC VII target BP of 140/90 mm Hg after 2 weeks of therapy <br/ ><br>Timepoint: 28 Days;â?¢Symptom relief: Defined as the absence of the clinical symptom of dyspnea and palpitations after 4 weeks of therapy <br/ ><br>Timepoint: 28 Days