NCT02944734

Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: Shin Poong Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Candesartan Cilexetil 8mg	Candesartan Cilexetil 8mg Daily oral administration for 8 weeks
DRUG	Candesartan Cilexetil 16mg	Candesartan Cilexetil 16mg Daily oral administration for 8 weeks
DRUG	Amlodipine 5mg	Amlodipine 5mg Daily oral administration for 8 weeks
DRUG	Amlodipine 10mg	Amlodipine 10mg Daily oral administration for 8 weeks

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2016-10-26
• Last updated: 2016-11-22

Locations

23 sites across 1 country: South Korea