Recruitment

Recruitment Status
Completed

Inclusion Criterias

An office sitting systolic blood pressure of ≥ 150 and < 180 mmHg, and an office sitting diastolic blood pressure of ≥ 95 and < 110 mmHg during the placebo run-in period at Week -2 and Week 0.
Male or female aged 20 years or older at the time of providing informed consent.
Outpatient.
...
An office sitting systolic blood pressure of ≥ 150 and < 180 mmHg, and an office sitting diastolic blood pressure of ≥ 95 and < 110 mmHg during the placebo run-in period at Week -2 and Week 0.
Male or female aged 20 years or older at the time of providing informed consent.
Outpatient.
Grade I or II essential hypertension.

Exclusion Criterias

Secondary hypertension, grade III hypertension or malignant hypertension.
An office sitting systolic blood pressure of ≥160 mmHg or sitting diastolic blood pressure of ≥100 mmHg recorded while on combined therapy with 3 or more antihypertensives within 4 weeks prior to the initiation of the placebo run-in period and at Week -4.
Secondary hypertension, grade III hypertension or malignant hypertension.
An office sitting systolic blood pressure of ≥160 mmHg or sitting diastolic blood pressure of ≥100 mmHg recorded while on combined therapy with 3 or more antihypertensives within 4 weeks prior to the initiation of the placebo run-in period and at Week -4.

Summary

Conditions
Grade I or II Essential Hypertension
Type
Interventional
Phase
Phase 2 & Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 125 years
Gender
Both males and females

Description

This study is a randomized, double-blind, multicenter, phase 2/3 study to evaluate the efficacy and safety of combined administration of TAK-536CCB and Hydrochlorothiazide (HCTZ) with those of TAK-536CCB or Hydrochlorothiazide in patients with grade I or II essential hypertension. This study consist...

This study is a randomized, double-blind, multicenter, phase 2/3 study to evaluate the efficacy and safety of combined administration of TAK-536CCB and Hydrochlorothiazide (HCTZ) with those of TAK-536CCB or Hydrochlorothiazide in patients with grade I or II essential hypertension. This study consists of a 4-week single-blind placebo run-in period and a 10-week double-blind treatment period.

Inclusion Criterias

An office sitting systolic blood pressure of ≥ 150 and < 180 mmHg, and an office sitting diastolic blood pressure of ≥ 95 and < 110 mmHg during the placebo run-in period at Week -2 and Week 0.
Male or female aged 20 years or older at the time of providing informed consent.
Outpatient.
...
An office sitting systolic blood pressure of ≥ 150 and < 180 mmHg, and an office sitting diastolic blood pressure of ≥ 95 and < 110 mmHg during the placebo run-in period at Week -2 and Week 0.
Male or female aged 20 years or older at the time of providing informed consent.
Outpatient.
Grade I or II essential hypertension.

Exclusion Criterias

Secondary hypertension, grade III hypertension or malignant hypertension.
An office sitting systolic blood pressure of ≥160 mmHg or sitting diastolic blood pressure of ≥100 mmHg recorded while on combined therapy with 3 or more antihypertensives within 4 weeks prior to the initiation of the placebo run-in period and at Week -4.
Secondary hypertension, grade III hypertension or malignant hypertension.
An office sitting systolic blood pressure of ≥160 mmHg or sitting diastolic blood pressure of ≥100 mmHg recorded while on combined therapy with 3 or more antihypertensives within 4 weeks prior to the initiation of the placebo run-in period and at Week -4.

Locations

Touon-shi, Ehime
Fukuoka-shi, Fukuoka
Sapporo-shi, Hokkaido
Morioka-shi, Iwate
Kyoto-shi, Kyoto
...
Touon-shi, Ehime
Fukuoka-shi, Fukuoka
Sapporo-shi, Hokkaido
Morioka-shi, Iwate
Kyoto-shi, Kyoto
Hanamaki-shi, Iwate
Shinjuku-ku, Tokyo
Osaka-shi, Osaka
Hiroshima-shi, Hiroshima
Toyama-shi, Toyama
Suita-shi, Osaka
Sendai-shi, Miyagi
Kumamoto-shi, Kumamoto

Tracking Information

NCT #
NCT02072330
Collaborators
Not Provided
Investigators
Study Director: Senior Manager Takeda