Diurnal Variation in Hypertensive Stroke Patients

Stroke Clinical Trial

Official title:

Comparison of the Effects of Amlodipine and Losartan on Blood Pressure and Diurnal Variation in Hypertensive Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830517
• Other study ID #: HM-AMO-401
• Status: Completed
• Phase: Phase 4
• First received: April 10, 2013
• Last updated: April 11, 2013
• Start date: August 2007
• Est. completion date: February 2012

Study information

• Verified date: April 2013
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Stroke

Intervention

Drug:
• Amlodipine, Losartan

Locations

Country	Name	City	State
Korea, Republic of	Boramae Medical Center	Boramae-ro 5-gil 20, Dongjak-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour ambulatory mean SBP		baseline and 8weeks	No
Secondary	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	No