Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB and Hydrochlorothiazide in Patients With Grade I or II Essential Hypertension.
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
This date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)
Study Completion
December 2013
Actual (reported)
Brief 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
353 participants
Study completion date
December 2013
Actual (reported)
Listed locations
1 countries · 13 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
March 2013
Date type not reported
This date has not been verified as actual or estimated.
Change from Baseline in the office trough sitting diastolic blood pressure (DBP)
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 \[LOCF\])
Baseline and Week 10
Secondary Outcomes (6)
Change from Baseline in the office trough sitting systolic blood pressure (SBP)
Baseline and Week 10
Proportion of patients achieving < 140/90 mmHg
10 weeks
Proportion of responders (140/90 mmHg criterion)
10 weeks
Frequency of adverse events( including vital sign, body weight, ECG findings and laboratory tests)
10 weeks
Time profile of office trough sitting diastolic blood pressure
10 weeks
+1 more secondary outcomes
Study Arms (5)
TAK-536CCB 20 mg/5 mg ＋Placebo (dual therapy)
ACTIVE COMPARATOR
TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide (HCTZ) placebo for 10 weeks
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.
Also known as: Fix-dose combination of Azilsartan and Amlodipine
TAK-536CCB 20 mg/5 mg ＋Placebo (dual therapy)
TAK-536CCB + HydrochlorothiazideDrug
TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide 6.25 mg tablets
Also known as:
Eligibility Criteria
Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
You may qualify if:
Grade I or II essential hypertension.
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.
Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesVascular Diseases
Study Officials
Senior Manager
Takeda
STUDY DIRECTOR
Enrollment
353 participants (actual enrollment reported by the registry).
Study Design
Study Type
interventional
Phase
phase 2 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Study Record Dates
First Submitted
February 24, 2014
First Posted
February 26, 2014
Study Start
March 2013
Date type not reported
This date has not been verified as actual or estimated.
NCT01822860
Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function
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
Placebo ＋HCTZ 6.25 mg (HCTZ monotherapy)
ACTIVE COMPARATOR
TAK-536CCB placebo and Hydrochlorothiazide 6.25 mg (HCTZ monotherapy) for 10 weeks from the start of the treatment period.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Male or female aged 20 years or older at the time of providing informed consent.
Outpatient.
You may not qualify if:
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.
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).
Advanced hypertensive retinopathy: bleeding, exudation, or papilledema (within 24 weeks before the placebo run-in period).
\. 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.
\. Diabetic subject on insulin treatment or poorly controlled type 2 diabetes mellitus.
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Source: ClinicalTrials.gov.
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