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Trial record 1 of 1 for:    TAK-536TCH/CCT-001
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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.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02072330
First Posted: February 26, 2014
Last Update Posted: February 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  Purpose
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.

Condition Intervention Phase
Grade I or II Essential Hypertension Drug: TAK-536CCB Drug: TAK-536CCB + Hydrochlorothiazide Drug: Hydrochlorothiazide Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Change from Baseline in the office trough sitting diastolic blood pressure (DBP) [ Time Frame: 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])


Secondary Outcome Measures:
  • Change from Baseline in the office trough sitting systolic blood pressure (SBP) [ Time Frame: Baseline and Week 10 ]
    Change in the office trough sitting SBP 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])

  • Proportion of patients achieving < 140/90 mmHg [ Time Frame: 10 weeks ]

    Patients achieving < 140/90 mmHg refer to those meeting both of the following criteria:

    • A decrease to < 90 mmHg in office trough sitting DBP
    • A decrease to < 140 mmHg in office trough sitting SBP

  • Proportion of responders (140/90 mmHg criterion) [ Time Frame: 10 weeks ]

    Patients who met either of the following conditions are regarded as responders (140/90 mmHg criterion).

    • A ≥ 20 mmHg decrease in office trough sitting SBP and a ≥ 10 mmHg decrease in the office trough sitting DBP
    • A decrease to < 140 mmHg in office trough sitting SBP and a decrease to < 90 mmHg in office trough sitting DBP

  • Frequency of adverse events( including vital sign, body weight, ECG findings and laboratory tests) [ Time Frame: 10 weeks ]
    The frequency of adverse events by type, seriousness. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug

  • Time profile of office trough sitting diastolic blood pressure [ Time Frame: 10 weeks ]
  • Time profile of office trough sitting systolic blood pressure [ Time Frame: 10 weeks ]

Enrollment: 353
Study Start Date: March 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TAK-536CCB 20 mg/5 mg +Placebo (dual therapy)
TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide (HCTZ) placebo for 10 weeks
Drug: TAK-536CCB
TAK-536CCB 20 mg/5 mg +Hydrochlorothiazide placebo tablets
Other Name: Fix-dose combination of Azilsartan and Amlodipine
Experimental: TAK-536CCB 20 mg/5 mg +HCTZ 6.25 mg (triple therapy)
TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide placebo (triple therapy) for the first 2 weeks of the treatment period and TAK-536CCB 20 mg/5 mg and HCTZ 6.25 mg for the remaining 8 weeks.
Drug: TAK-536CCB + Hydrochlorothiazide
TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide 6.25 mg tablets
Other Name: Hydrochlorothiazide and fix-dose combination of Azilsartan and Amlodipine
Experimental: TAK-536CCB 20 mg/5 mg +HCTZ 12.5 mg (triple therapy)
TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide placebo for the first 2 weeks of the treatment period and TAK-536CCB 20 mg/5 mg and HCTZ 12.5 mg (triple therapy) for the remaining 8 weeks.
Drug: TAK-536CCB + Hydrochlorothiazide
TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide 6.25 mg tablets x2
Other Name: Hydrochlorothiazide and fix-dose combination of Azilsartan and Amlodipine
Active Comparator: Placebo +HCTZ 6.25 mg (HCTZ monotherapy)
TAK-536CCB placebo and Hydrochlorothiazide 6.25 mg (HCTZ monotherapy) for 10 weeks from the start of the treatment period.
Drug: Hydrochlorothiazide
TAK-536CCB placebo and Hydrochlorothiazide 6.25 mg tablets
Active Comparator: Placebo +Hydrochlorothiazide 12.5 mg (HCTZ monotherapy)
TAK-536CCB placebo and Hydrochlorothiazide 12.5 mg (HCTZ monotherapy) for 10 weeks from the start of the treatment period.
Drug: Hydrochlorothiazide
TAK-536CCB placebo and Hydrochlorothiazide 6.25 mg tablets x2

Detailed 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 consists of a 4-week single-blind placebo run-in period and a 10-week double-blind treatment period.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Grade I or II essential hypertension.
  2. 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.
  3. Male or female aged 20 years or older at the time of providing informed consent.
  4. Outpatient.

Exclusion Criteria:

  1. Secondary hypertension, grade III hypertension or malignant hypertension.
  2. 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.

3 Evident white coat hypertension or white coat phenomenon. 4. Day-night reversed lifestyle, such as night-time workers. 5. Sleep apnea syndrome requiring treatment. 6. Have any of the cardiovascular disease or symptoms listed below:

  • Heart disease: myocardial infarction (within 24 weeks before the placebo run-in period), coronary arterial revascularization (within 24 weeks before the placebo run-in period), severe valvular disease, atrial fibrillation, or following diseases which require medication: angina pectoris, congested heart failure, or arrhythmia.
  • Cerebrovascular disease: cerebral infarction, cerebral hemorrhage (within 24 weeks before the placebo run-in period), or transient ischemic attack (within 24 weeks before the placebo run-in period).
  • Vascular diseases: peripheral arterial disease with intermittent claudication, artery dissection, aneurysm
  • Advanced hypertensive retinopathy: bleeding, exudation, or papilledema (within 24 weeks before the placebo run-in period).

    7. Clinically significant hepatic disorder. 8. Clinically significant renal impairment. 9. Significantly low or high Potassium or Sodium levels. 10. Complicated by gout, or had a past history of gout within 24 weeks prior to the initiation of the placebo run-in period, or complicated by hyperuricemia requiring medication.

    11. Diabetic subject on insulin treatment or poorly controlled type 2 diabetes mellitus.

    12. Have a malignant tumor.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072330


Locations
Japan
Touon-shi, Ehime, Japan
Fukuoka-shi, Fukuoka, Japan
Hiroshima-shi, Hiroshima, Japan
Sapporo-shi, Hokkaido, Japan
Hanamaki-shi, Iwate, Japan
Morioka-shi, Iwate, Japan
Kumamoto-shi, Kumamoto, Japan
Kyoto-shi, Kyoto, Japan
Sendai-shi, Miyagi, Japan
Osaka-shi, Osaka, Japan
Suita-shi, Osaka, Japan
Shinjuku-ku, Tokyo, Japan
Toyama-shi, Toyama, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Manager Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02072330     History of Changes
Other Study ID Numbers: TAK-536TCH/CCT-001
JapicCTI-121962 ( Registry Identifier: Japic CTI )
First Submitted: February 24, 2014
First Posted: February 26, 2014
Last Update Posted: February 26, 2014
Last Verified: February 2014

Keywords provided by Takeda:
Hypertension, Drug therapy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Hydrochlorothiazide
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors