AMISH : Aprovel for Management of Isolated Systolic Hypertension

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00264212
First received: December 9, 2005
Last updated: December 17, 2007
Last verified: December 2007
  Purpose

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 Intervention Phase
Hypertension
Drug: irbesartan and irbesartan-hydrochlorothiazide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 436
Study Start Date: August 2004
  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264212

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

No publications provided

ClinicalTrials.gov Identifier: NCT00264212     History of Changes
Other Study ID Numbers: R_8791
Study First Received: December 9, 2005
Last Updated: December 17, 2007
Health Authority: Indonesia : National Agency of Drug and Food Control (NA-DFC)

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Irbesartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 22, 2014