Diurnal Variation in Hypertensive Stroke Patients

NCT01830517 | Completed Phase 4

• 1 other identifier: HM-AMO-401
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 24-hour ambulatory mean SBP

  baseline and 8weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

amlodipine camsylate

EXPERIMENTAL

amlodipine camsylate 5mg

Drug: Amlodipine, Losartan

losartan potassium

ACTIVE COMPARATOR

losartan potassium 50mg

Drug: Amlodipine, Losartan

Interventions

Amlodipine, Losartan DRUG

amlodipine camsylate; losartan potassium

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 35 to 85 years
• hypertensive patients who had an ischemic stroke

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Boramae Medical Center

Boramae-ro 5-gil 20, Dongjak-gu, Seoul, 156-707, South Korea

Location

Related Publications (1)

• 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.

  PMID: 24296324 DERIVED

MeSH Terms

Conditions

Hypertension; Stroke

Interventions

amlodipine-losartan drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hyunwoo Nam, M.D., Ph.D.

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: April 12, 2013
• Study Start: August 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: February 1, 2012
• Last Updated: April 12, 2013

Record last verified: 2013-04

Locations

KR (1)