Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB and Hydrochlorothiazide in Patients With Grade I or II Essential Hypertension.
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Grade I or II essential hypertension.
- Outpatient.
- Male or female aged 20 years or older at the time of providing informed consent.
- ...
- Grade I or II essential hypertension.
- Outpatient.
- Male or female aged 20 years or older at the time of providing informed consent.
- 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.
Exclusion Criteria
- 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 2Phase 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 Criteria
- Grade I or II essential hypertension.
- Outpatient.
- Male or female aged 20 years or older at the time of providing informed consent.
- ...
- Grade I or II essential hypertension.
- Outpatient.
- Male or female aged 20 years or older at the time of providing informed consent.
- 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.
Exclusion Criteria
- 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.
Tracking Information
- NCT #
- NCT02072330
- Collaborators
- Not Provided
- Investigators
- Study Director: Senior Manager Takeda
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