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Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB and Hydrochlorothiazide in Patients With Grade I or II Essential Hypertension.

NCT02072330 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2014-02-26

No results posted yet for this study

Summary

The objective of this study is to compare the efficacy and safety of combined administration of TAK-536CCB (Fix-dose combination of Azilsartan and Amlodipine) and Hydrochlorothiazide (HCTZ) with those of TAK-536CCB in patients with Grade I or II essential hypertension.

Conditions

  • Grade I or II Essential Hypertension

Interventions

DRUG

TAK-536CCB

TAK-536CCB 20 mg/5 mg ＋Hydrochlorothiazide placebo tablets

DRUG

TAK-536CCB + Hydrochlorothiazide

TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide 6.25 mg tablets

DRUG

Hydrochlorothiazide

TAK-536CCB placebo and Hydrochlorothiazide 6.25 mg tablets

DRUG

Hydrochlorothiazide

TAK-536CCB placebo and Hydrochlorothiazide 6.25 mg tablets x2

DRUG

TAK-536CCB + Hydrochlorothiazide

TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide 6.25 mg tablets x2

Sponsors & Collaborators

Principal Investigators

  • Senior Manager · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02072330 on ClinicalTrials.gov