Conditions: Essential Hypertension
Keywords: Pharmacological therapy Drug Therapy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 341
Healthy volunteers: no

Brief 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.

Arms:
arm 1: For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.

For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg orally, once daily, before or after breakfast.

Interventions: intervention 1: TAK-536TCH tablet intervention 2: TAK-536CCB tablet intervention 3: HCTZ 12.5 mg tablet
Intervention descriptions: intervention 1: TAK-536TCH tablets intervention 2: TAK-536CCB tablets intervention 3: HCTZ tablets

Protocol document: