NCT02969265

An Efficacy and Safety Study Evaluating the Fixed-Dose Combination of Candesartan Plus Amlodipine in Participants With Mild/Moderate Essential Hypertension

A Phase-3 Randomized, Double-Blind, Parallel-Group Efficacy and Safety Study Evaluating the Fixed-Dose Combination of Candesartan Plus Amlodipine (8/5 mg) in Chinese Subjects With Mild/Moderate Essential Hypertension, Who Do Not Achieve Target Blood Pressure Following Treatment With Amlodipine 5 mg Monotherapy

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of TCV-116CCB (candesartan cilexetil and amlodipine besylate fixed-dose combination) in Chinese participants with mild to moderate hypertension who do not reach target blood pressure following 4 weeks of treatment with amlodipine monotherapy.

Detailed description

The drug being tested in this study is called TCV-116CCB (candesartan cilexetil and amlodipine besylate fixed-dose combination). This study will look at blood pressure in Chinese participants with grade 1 or 2 essential hypertension. The study will enroll approximately 370 patients. Prior to the start of study treatment, participants will undergo run-in period of 2 weeks followed by single-blind treatment period of 4 weeks. Upon completion of single-blind treatment period, participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Amlodipine 5 mg * TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg) All participants will be asked to take one tablet/capsule at the same time each day throughout the study up to 8 weeks. This multicenter trial will be conducted China. The overall time to participate in this study is 19 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone plus a final visit 14 days after receiving their last dose of drug for a follow-up assessment.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Amlodipine	Amlodipine Capsules
DRUG	TCV-116CCB	TCV-116CCB Tablets
DRUG	Amlodipine Placebo	Amlodipine placebo-matching capsules
DRUG	TCV-116CCB Placebo	TCV-116CCB 8/5 mg placebo-matching tablets

Timeline

• Start date: 2017-05-09
• Primary completion: 2018-07-12
• Completion: 2018-07-26
• First posted: 2016-11-21
• Last updated: 2017-06-09

Locations

25 sites across 1 country: China