Hypertension
Conditions
Keywords
amlodipine, losartan, hypertension, stage 2
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.
Interventions
amlodipine 5mg/losartan 50mg, amlodipine 10mg/losartan 50mg (+HCTZ 12.5mg)
DRUGamlodipine
amlodipine 5mg, amlodipine 10mg (+ HCTZ 12.5mg)
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in MSSBP | Baseline, Week 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed