Diurnal Variation in Hypertensive Stroke Patients

Hanmi Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Hypertension; Stroke

Treatments: Drug: Amlodipine, Losartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01830517

HM-AMO-401

Details and patient eligibility

About

This study was conducted to evaluate and compare the effectiveness of Amodipin® (amlodipine camsylate) with that of Cozaar® (losartan potassium) in hypertensive patients with an acute ischemic stroke by measuring their 24-hour ambulatory BP (ABP).

Enrollment: 84 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. aged 35 to 85 years
2. hypertensive patients who had an ischemic stroke

Exclusion criteria

1. patients aged below 35 years or above 86 years;
2. patients who had a hemorrhagic stroke;
3. patients whose systolic BP (SBP) was over 220 mmHg or whose diastolic BP (DBP) was above 120 mmHg during an acute phase, or whose SBP was over 180 mmHg or whose DBP was over 110 mmHg one week after their hospital visit;
4. patients with secondary hypertension related to renovascular, endocrinologic, or pregnant conditions
5. patients who went to bed in the middle of the day or very late at night; (6) patients who were using intravenous antico-agulants or thrombolytics;

(7) patients with a severe stroke (NIH stroke scale > 20); (8) patients who could not give their consent to investigators; (9) patients with severely impaired liver function (AST or ALT ≥ 100); (10) patients with severely impaired renal function (serum creatinine ≥ 2.0 mg/dL); (11) patients with cancer; (12) patients who were pregnant or lactating; (13) patients with other grave diseases such as hypertensive encephalopathy, aortic dissection, acute myocardial infarction, or severe congestive heart failure; and (14) patients who were allergic to the test or control drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

amlodipine camsylate

Experimental group

Description:

amlodipine camsylate 5mg

Treatment:

Drug: Amlodipine, Losartan

losartan potassium

Active Comparator group

Description:

losartan potassium 50mg

Treatment:

Drug: Amlodipine, Losartan