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AMISH : Aprovel for Management of Isolated Systolic Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00264212
Recruitment Status : Completed
First Posted : December 12, 2005
Last Update Posted : December 21, 2007
Bristol-Myers Squibb
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Brief Summary:
To compare the antihypertensive efficacy and tolerability of irbesartan and irbesartan-hydrochlorothiazide fixed combination therapy with amlodipine and amlodipine plus hydrochlorothiazide in the treatment of isolated systolic hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Drug: irbesartan and irbesartan-hydrochlorothiazide Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre Prospective Randomized Open-Label 12-Week Study With Blinded Evaluation Comparing the Efficacy and Safety of Irbesartan and Irbesartan-Hydrochlorothiazide Fixed Combination With Amlodipine and Amlodipine Plus Hydrochlorothiazide in Elderly Patients With Isolated Systolic Hypertension
Study Start Date : August 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change from baseline in office seated SBP at week 12

Secondary Outcome Measures :
  1. At 4, 8 and 12 weeks: Number of responders and normalized, Change from baseline in pulse pressure (SBP-DBP), Change from baseline in standing SBP, Safety : Change in standing SBP/DBP, incidence of orthostatic hypotension, adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main criteria are listed hereafter:

Inclusion Criteria:

  • at Screening

    • Outpatients
    • With newly diagnosed and untreated OR previously diagnosed, treated and uncontrolled Isolated Systolic Hypertension defined as:

      • seated Systolic Blood Pressure (SBP) ≥ 160mmHg and < 220 mmHg [160-220[
      • AND seated Diastolic Blood Pressure (DBP)< 90 mmHg
  • at Randomization

    • Having completed the 2 to 4-week wash-out/placebo run-in phase
    • Still eligible for Blood Pressure
    • seated SBP ≥ 160mmHg and < 220 mmHg [160-220[
    • AND seated DBP < 90 mmHg.

Exclusion Criteria (at Screening):

  • Participation in a clinical trial within the previous 3 months
  • Patients with a history of irbesartan, amlodipine, or hydrochlorothiazide sensitivity defined as irbesartan, amlodipine, or hydrochlorothiazide discontinuation due to medically significant adverse effects
  • Patients currently or previously treated with Angiotensin II Receptor Blocker (irbesartan, losartan, candesartan, valsartan, telmisartan, etc.) or dihydropiridine Calcium Channel Blocker (amlodipine, nicardipine, felodipine, nifedipine, etc.) AND not responding despite maximum tolerated dose
  • Known or suspected secondary hypertension (e.g., coarctation of aorta, renovascular stenosis, etc.)
  • Known single functional kidney
  • History of recent myocardial infarction, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty, or cerebrovascular accident (Transient Ischaemic Attack, stroke) within the last 6 months of study entry
  • Patients with known gastrointestinal, renal, hepatic, endocrine, cardiovascular, pulmonary, immunological or hematological disease which in the opinion of the investigator is active or uncontrolled
  • Patients with significant renal (clearance of creatinine < 30 mL/mn), hepatic or cardiac insufficiency, or known valvular heart disease
  • Serum potassium < 3.5 mmol/L (mEq/L) or > 5.5 mmol/L (mEq/L)
  • Presence of clinically significant ventricular or supraventricular arrhythmias, or second or third degree atrioventricular block, or QTc prolongation (Bazett > 450 msec.) on the ECG
  • Pregnancy or lactation. Women of child bearing potential (not post-menopausal) should be using a reliable contraceptive method

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00264212

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Santiago, Chile
Shangai, China
Jakarta, Indonesia
Korea, Republic of
Seoul, Korea, Republic of
Mexico, Mexico
Manila, Philippines
Taipei, Taiwan
Bangkok, Thailand
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Pascale BLONDIN, MD Sanofi

Layout table for additonal information Identifier: NCT00264212     History of Changes
Other Study ID Numbers: R_8791
First Posted: December 12, 2005    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists