Who is sponsoring NCT02072330?

NCT02072330 is sponsored by Takeda.

What condition does NCT02072330 study?

NCT02072330 studies Grade I or II Essential Hypertension.

What drugs are being tested in NCT02072330?

Interventions: TAK-536CCB, TAK-536CCB + Hydrochlorothiazide, Hydrochlorothiazide, Hydrochlorothiazide, TAK-536CCB + Hydrochlorothiazide.

What is the status of NCT02072330?

NCT02072330 is currently COMPLETED.

Last reviewed 2014-02-24 · How we verify

A Randomized, Double-Blind, Multicenter, Phase 2/3 Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB (Fix-dose Combination of Azilsartan and Amlodipine) and Hydrochlorothiazide in Comparison With TAK-536CCB or Hydrochlorothiazide Monotherapy in Patients With Grade I or II Essential Hypertension

NCT02072330 Phase 2/Phase 3 COMPLETED

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.

Details

Lead sponsor	Takeda
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	353
Start date	2013-03
Completion	2013-12

Conditions

Grade I or II Essential Hypertension

Interventions

TAK-536CCB
TAK-536CCB + Hydrochlorothiazide
Hydrochlorothiazide
Hydrochlorothiazide
TAK-536CCB + Hydrochlorothiazide

Primary outcomes

Change from Baseline in the office trough sitting diastolic blood pressure (DBP) — Baseline and Week 10
Change in the office trough sitting DBP from the end of the placebo run-in period (baseline \[Week 0\]) to the end of the treatment period (Week 10, last observation carried forward \[LOCF\])

Countries

Japan