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
  Purpose

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).


Condition Intervention Phase
Hypertension
Stroke
Drug: Amlodipine, Losartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Effects of Amlodipine and Losartan on Blood Pressure and Diurnal Variation in Hypertensive Stroke Patients

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • 24-hour ambulatory mean SBP [ Time Frame: baseline and 8weeks ] [ Designated as safety issue: No ]

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 [ Time Frame: baseline and 8weeks ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: August 2007
Study Completion Date: February 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: amlodipine camsylate
amlodipine camsylate 5mg
Drug: Amlodipine, Losartan
Active Comparator: losartan potassium
losartan potassium 50mg
Drug: Amlodipine, Losartan

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01830517

Locations
Korea, Republic of
Boramae Medical Center
Boramae-ro 5-gil 20, Dongjak-gu, Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Hyunwoo Nam, M.D., Ph.D. SMG-SNU Boramae Medical Center
  More Information

No publications provided by Hanmi Pharmaceutical Company Limited

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01830517     History of Changes
Other Study ID Numbers: HM-AMO-401
Study First Received: April 10, 2013
Last Updated: April 11, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Stroke
Cerebral Infarction
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia
Amlodipine
Losartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on April 17, 2014