Back to resultsDiurnal Variation in Hypertensive Stroke Patients
Primary Purpose
Hypertension, Stroke
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Amlodipine, Losartan
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- aged 35 to 85 years
- hypertensive patients who had an ischemic stroke
Exclusion Criteria:
- patients aged below 35 years or above 86 years;
- patients who had a hemorrhagic stroke;
- 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;
- patients with secondary hypertension related to renovascular, endocrinologic, or pregnant conditions
- 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
Sites / Locations
- Boramae Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
amlodipine camsylate
losartan potassium
Arm Description
amlodipine camsylate 5mg
losartan potassium 50mg
Outcomes
Primary Outcome Measures
24-hour ambulatory mean SBP
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01830517
First Posted
April 10, 2013
Last Updated
April 11, 2013
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT01830517
Brief Title
Diurnal Variation in Hypertensive Stroke Patients
Official Title
Comparison of the Effects of Amlodipine and Losartan on Blood Pressure and Diurnal Variation in Hypertensive Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
amlodipine camsylate
Arm Type
Experimental
Arm Description
amlodipine camsylate 5mg
Arm Title
losartan potassium
Arm Type
Active Comparator
Arm Description
losartan potassium 50mg
Intervention Type
Drug
Intervention Name(s)
Amlodipine, Losartan
Primary Outcome Measure Information:
Title
24-hour ambulatory mean SBP
Time Frame
baseline and 8weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
baseline and 8weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 35 to 85 years
hypertensive patients who had an ischemic stroke
Exclusion Criteria:
patients aged below 35 years or above 86 years;
patients who had a hemorrhagic stroke;
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;
patients with secondary hypertension related to renovascular, endocrinologic, or pregnant conditions
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyunwoo Nam, M.D., Ph.D.
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boramae Medical Center
City
Boramae-ro 5-gil 20, Dongjak-gu
State/Province
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24296324
Citation
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.
Results Reference
derived
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Diurnal Variation in Hypertensive Stroke Patients
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