Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension
Status and phase
Completed
Phase 3
Conditions
Hypertension
Treatments
Drug: amlodipine/losartan
Drug: amlodipine
Details and patient eligibility
About
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.
Enrollment
149 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
149 participants in 2 patient groups
amlodipine/losartan
Experimental group
Treatment:
Drug: amlodipine/losartan
amlodipine
Active Comparator group
Treatment:
Drug: amlodipine
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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