NCT02368665

A Study to Evaluate the Efficacy and Safety of Amlodipine Besylate and Candesartan Cilexetil in Essential Hypertension Patient Who Are Not Adequately Controlled With Amlodipine Besylate Monotherapy

A Randomized, Double-blind, Multi-center, Phase III Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Amlodipine Besylate and Candesartan Cilexetil Combination in Patients With Essential Hypertension Who Are Not Adequately Controlled With Amlodipine Besylate Monotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Compare the safety and efficacy of amlodipine besylate and candesartan cilexetil combination therapy on patients of essential hypertension who are not properly controlled by amlodipine besylate monotherapy.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Amlodipine 5mg	\- Daily oral administration for 8 weeks
DRUG	Amlodipine 5mg, Candesartan cilexetil 16mg	\- Daily oral administration Amlodipine 5mg for 8 weeks
DRUG	Amlodipine 10mg, Candesartan cilexetil 16mg	\- After 8 weeks of administration, Amlodipine 10mg and Candesartan cilexetil 16mg once a day for 8 weeks

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-11-01
• Completion: 2016-11-01
• First posted: 2015-02-23
• Last updated: 2023-05-06

Locations

19 sites across 1 country: South Korea