Diurnal Variation in Hypertensive Stroke Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01830517
First received: April 10, 2013
Last updated: April 11, 2013
Last verified: April 2013

April 10, 2013
April 11, 2013
August 2007
June 2011   (final data collection date for primary outcome measure)
24-hour ambulatory mean SBP [ Time Frame: baseline and 8weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01830517 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Diurnal Variation in Hypertensive Stroke Patients
Comparison of the Effects of Amlodipine and Losartan on Blood Pressure and Diurnal Variation in Hypertensive Stroke Patients

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hypertension
  • Stroke
Drug: Amlodipine, Losartan
  • Experimental: amlodipine camsylate
    amlodipine camsylate 5mg
    Intervention: Drug: Amlodipine, Losartan
  • Active Comparator: losartan potassium
    losartan potassium 50mg
    Intervention: Drug: Amlodipine, Losartan
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
February 2012
June 2011   (final data collection date for primary outcome measure)

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

Both
35 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01830517
HM-AMO-401
No
Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
Not Provided
Principal Investigator: Hyunwoo Nam, M.D., Ph.D. SMG-SNU Boramae Medical Center
Hanmi Pharmaceutical Company Limited
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP