NCT02059616

A Phase 2 Dose Selection Trial of Candesartan Cilexetil and Amlodipine Besylate to Treat Essential Hypertension

A Randomized, Double-blind, Multi-center, PhaseⅡ Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Candesartan Cilexetil and Amlodipine Besylate for the Dose Selection in Patients With Essential Hypertension

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 75 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	Amlodipine 5mg	Daily oral administration for 8 weeks
DRUG	Amlodipine 10mg	Daily oral administration for 8 weeks
DRUG	Candesartan Cilexetil 8mg	Daily oral administration for 8 weeks
DRUG	Candesartan cilexetil 16mg	Daily oral administration for 8 weeks

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-06-01
• Completion: 2015-12-01
• First posted: 2014-02-11
• Last updated: 2014-04-30

Locations

20 sites across 1 country: South Korea