Clinical trial NCT02072330: Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB and Hydrochlorothiazide in Patients With Grade I or II Essential Hypertension.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Grade I or II Essential Hypertension
Keywords: Hypertension, Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 353
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Change from Baseline in the office trough sitting diastolic blood pressure (DBP)
timeFrame: Baseline and Week 10
Secondary outcomes:
measure: Change from Baseline in the office trough sitting systolic blood pressure (SBP)
timeFrame: Baseline and Week 10
measure: Proportion of patients achieving < 140/90 mmHg
timeFrame: 10 weeks
measure: Proportion of responders (140/90 mmHg criterion)
timeFrame: 10 weeks
measure: Frequency of adverse events( including vital sign, body weight, ECG findings and laboratory tests)
timeFrame: 10 weeks
measure: Time profile of office trough sitting diastolic blood pressure
timeFrame: 10 weeks
measure: Time profile of office trough sitting systolic blood pressure
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Touon-shi
country: Japan
state: Ehime
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Hiroshima-shi
country: Japan
state: Hiroshima
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Hanamaki-shi
country: Japan
state: Iwate
city: Morioka-shi
country: Japan
state: Iwate
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Kyoto-shi
country: Japan
state: Kyoto
city: Sendai-shi
country: Japan
state: Miyagi
city: Osaka-shi
country: Japan
state: Osaka
city: Suita-shi
country: Japan
state: Osaka
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Toyama-shi
country: Japan
state: Toyama
Study officials:
affiliation: Takeda
name: Senior Manager
role: STUDY_DIRECTOR
References: