A Multi-center, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy vs. Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension

NCT02944734 Phase 2 COMPLETED

The purpose of this study is to explore the optimal dose of fixed-dose combination of candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the combination therapy compared to each of the monotherapy in patients with essential hypertension.

Details

Lead sponsor	Shin Poong Pharmaceutical Co. Ltd.
Phase	Phase 2
Status	COMPLETED
Enrolment	392
Start date	2014-09
Completion	2015-12

Conditions

• Essential Hypertension

Interventions

• Candesartan Cilexetil 8mg
• Candesartan Cilexetil 16mg
• Amlodipine 5mg
• Amlodipine 10mg

Primary outcomes

• Change mean sitting Diastolic Blood Pressure (msDBP) at week 8 compared to baseline — Week 8

Countries

South Korea