Abstract

Aims: The present clinical study was conducted to establish non-inferiority of efonidipine hydrochloride ethanolate (efonidipine) as compared to amlodipine besylate (amlodipine) in the management of Stage-I hypertension.

Study Design: The study was a prospective, cohort, double-blind, double-dummy, randomized phase-Ill clinical trial

Place and Duration of Study: Nine geographically distributed sites across India were involved in the clinical trial between January 2015 to June 2016.

Background: The use of conventional L-type CCSs is often limited due to associated side effects. Efonidipine, a dual T- and L-type Ca2 + channel blocker has been proven to exhibit antihypertensive effect along with renoprotective actions with minimum systemic side effects. The present clinical study was conducted to evaluate the safety and efficacy of efonidipine for the first time in Indian patients with Stage-I hypertension.

Methodology: The present phase-Ill clinical trial was a double-blind, double-dummy, multi-center, and parallel group study conducted on the Indian population. A total of 200 patients were randomized to receive either efonidipine 40 mg (n=95) or amlodipine 5 mg (n=105) once daily for 28 days. The patients were evaluated for changes in the systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate.

Results: Efonidipine reduced SBP by 18.2 ± 12.2 mmHg, DBP by 10.7 ± 7.0 mmHg and heart rate was diminished by 8.1 ± 8.3 bpm while amlodipine reduced SBP by 19.2 ± 11.8 mmHg, DBP by 10.2 ± 7.7 mmHg and heart rate by 7.2 ± 9.9 bpm.

Conclusion: Efonidipine was concluded to be non-inferior to amlodipine in the reduction of SBD, DBP, and heart rate and was found to be comparable to amlodipine in the management of hypertension and its safety profile.

Clinical Trial Registration: The trial was registered with the Clinical Trial Registry of India; Reg. No: CTR1/2015/01/005359; Available at: http://ctri.nic.in/Clinicaltrials/showallp.php?mid1 =7747&EncHid=&userName=CTRI/20 15/01/005359