Diurnal Variation in Hypertensive Stroke Patients

NCT ID: NCT01830517

Last Updated: 2013-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2012-02-29

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).

Conditions

Hypertension; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

amlodipine camsylate

amlodipine camsylate 5mg

Group Type: EXPERIMENTAL

Amlodipine, Losartan

Intervention Type: DRUG

losartan potassium

losartan potassium 50mg

Group Type: ACTIVE_COMPARATOR

Amlodipine, Losartan

Intervention Type: DRUG

Interventions

Amlodipine, Losartan

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyunwoo Nam, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Locations

Boramae Medical Center

Boramae-ro 5-gil 20, Dongjak-gu, Seoul, South Korea

Countries

South Korea

References

Kwon HM, Shin JW, Lim JS, Hong YH, Lee YS, Nam H. Comparison of the effects of amlodipine and losartan on blood pressure and diurnal variation in hypertensive stroke patients: a prospective, randomized, double-blind, comparative parallel study. Clin Ther. 2013 Dec;35(12):1975-82. doi: 10.1016/j.clinthera.2013.10.013. Epub 2013 Dec 2.

Reference Type: DERIVED

PMID: 24296324 (View on PubMed)

Other Identifiers

HM-AMO-401

Identifier Type: -

Identifier Source: org_study_id