Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension
- Registration Number
- NCT01127217
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensive patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
Inclusion Criteria
- 18 aged or over
- Patients with blood pressure measured at Visit 1; MSSBP≤180mmHg and MSDBP≤110 mmHg if on anti-hypertensive drugs, 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg if not on anti-hypertensive drugs
- Patients with blood pressure measured at Visit 2 were 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg
Exclusion Criteria
- Inability to stop all prior anti-hypertensive drugs safely during wash out period of 3 to 7 days
- ≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
- History of hypersensitivity to dihydropyridines, angiotensin II receptor blockers or thiazide diuretics
- Secondary hypertension or suspected to be
- Continuously took medicinal drugs that might affect blood pressure rather than anti-hypertensive drugs more than 3 months
- Type 2 diabetes mellitus which is not controlled or with type 1 diabetes mellitus
- History of severe neurovascular disease, severe heart disease
- Known as moderate or malignant retinopathy.
- Renal diseases; serum creatinine ≥ 2mg/dl
- Hepatic diseases; increase in ALT or AST ≥ 2xUNL
- Anuria
- Hyponatremia/hypokalemia or hypercalcemia
- Active Gout
- Surgical or medical diseases which might significantly change ADME of medicines
- History of malignant tumor
- Autoimmune diseases
- History of alcohol or drug abuse
- Positive to pregnancy test, nursing mother, woman with an intention of pregnancy
- Considered inappropriate to participate in the clinical trial with any reason, based on investigator's decision
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description amlodipine/losartan amlodipine/losartan - amlodipine amlodipine -
- Primary Outcome Measures
Name Time Method Change from baseline in MSSBP Baseline, Week 6
- Secondary Outcome Measures
Name Time Method Change from baseline in MSSBP Baseline, Week 2 and 8 Change from baseline MSDBP Baseline, Week 2, 6, and 8 Blood pressure responder rate Baseline, Week 2, 6, 8 Rate of patients who achieved target blood pressure (MSSBP \< 140 mmHg or MSDBP \< 90 mmHg), or MSSBP decrease \> 20 mmHg from baseline or MSDBP decrease \> 10 mmHg from baseline.
Trial Locations
- Locations (1)
8 Sites
🇰🇷Seoul, Korea, Republic of