NCT02277691

A Phase III Long-term Study of TAK-536TCH in Participants With Essential Hypertension

A Phase 3, Open-label, Multicenter, Long-term Study to Evaluate the Safety and Efficacy of TAK-536, Amlodipine and Hydrochlorothiazide in Subjects With Essential Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 341 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of long-term administration of TAK-536, amlodipine (AML), and hydrochlorothiazide (HCTZ) in participants with essential hypertension.

Detailed description

The drug being tested in this study is called TAK-536TCH. TAK-536TCH is being tested to treat people who have essential hypertension. The study looked at effectiveness and long-term safety of TAK-536TCH in people who took TAK-536CCB in addition to standard care. The study enrolled 341 patients. Participants received: * TAK-536CCB (as TAK-536/AML, 20 mg/5 mg) in run-in period, * TAK-536TCH (as TAK-536/ AML/HCTZ, 20 mg/5 mg/12.5 mg) in treatment period * TAK-536CCB and HCTZ 12.5 mg in treatment period All participants were asked to take tablets at the same time each day throughout the study. This multi-center trial was conducted in Japan. The overall time to participate in this study was 56 weeks (4 weeks run-in period and 52 weeks treatment period). Participants made multiple visits to the clinic during the study.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	TAK-536TCH tablet	TAK-536TCH tablets
DRUG	TAK-536CCB tablet	TAK-536CCB tablets
DRUG	HCTZ 12.5 mg tablet	HCTZ tablets

Timeline

• Start date: 2014-11-07
• Primary completion: 2016-04-25
• Completion: 2016-04-25
• First posted: 2014-10-29
• Last updated: 2017-08-02
• Results posted: 2017-06-26

Locations

38 sites across 1 country: Japan