Diurnal Variation in Hypertensive Stroke Patients

Phase 4

Completed

• Conditions: Hypertension; Stroke
• Interventions: Drug: Amlodipine, Losartan

• Registration Number: NCT01830517
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2011-06
• Study Completion: 2012-02
• Status Verified: 2013-04
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-11
• Last Update Submitted: 2013-04-11
• Study First Posted: 2013-04-12
• Last Update Posted: 2013-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amlodipine camsylate	Amlodipine, Losartan	amlodipine camsylate 5mg
losartan potassium	Amlodipine, Losartan	losartan potassium 50mg

Primary Outcome Measures

Name	Time	Method
24-hour ambulatory mean SBP	baseline and 8weeks

Secondary Outcome Measures

Name	Time	Method
24H mean DBP, 24H mean SBP/DBP Variability,clinic SBP/DBP, awake, sleep, morning, evening, and prewake BPs, the morning surge, and the nocturnal dipping	baseline and 8weeks

Trial Locations

Locations (1)

Boramae Medical Center; 🇰🇷 Boramae-ro 5-gil 20, Dongjak-gu, Seoul, Korea, Republic of