Grade I or II Essential Hypertension Clinical Trial
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
| Verified date | February 2014 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 353 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Change from Baseline in the office trough sitting systolic blood pressure (SBP) | 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]) | Baseline and Week 10 | No |
| Secondary | Proportion of patients achieving < 140/90 mmHg | 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 |
10 weeks | No |
| Secondary | Proportion of responders (140/90 mmHg criterion) | 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 |
10 weeks | No |
| Secondary | Frequency of adverse events( including vital sign, body weight, ECG findings and laboratory tests) | 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 | 10 weeks | Yes |
| Secondary | Time profile of office trough sitting diastolic blood pressure | 10 weeks | No | |
| Secondary | Time profile of office trough sitting systolic blood pressure | 10 weeks | No |