Clinical trial to evaluate the Efficacy and Tolerability of Efonidipine in the treatment of Hypertension

Phase 3

Completed

• Conditions: Essential (primary) hypertension,

• Registration Number: CTRI/2015/01/005359
• Lead Sponsor: Zuventus Healthcare Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-30
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Proportion of patients achieving JNC VII target BP of 140/90 mm Hg by the end of treatment	28 Days
•Proportion of patients achieving heart rate 83 beats per minute by the end of treatment (as per Framingham Heart Study)	28 Days

Secondary Outcome Measures

Name	Time	Method
•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

Trial Locations

Locations (12)

B. Y. L. Nair Charitable Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Divine Heart and Multispeciality Hospital, Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

Indira Gandhi Government Medical College and Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Institute of Post Graduate Medical Education & Research , Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

King George Hospital Andhra Medical College, Visakhapatnam; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

MVP Samajs Dr. Vasantrao Pawar Medical College, Hospital & Research Centre; 🇮🇳 Nashik, MAHARASHTRA, India

Nizam Institute of Medical Sciences; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Omega Hospital, Mangalore; 🇮🇳 Kannada, KARNATAKA, India

Rajiv Gandhi Institute of Medical Sciences; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Sanjay Gandhi Post Graduate Institute of Medical Sciences; 🇮🇳 Lucknow, UTTAR PRADESH, India

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B. Y. L. Nair Charitable Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Girish Rajadhyaksha

Principal investigator

9821695349

girishraj63@gmail.com