Status:
COMPLETED
AMISH : Aprovel for Management of Isolated Systolic Hypertension
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Hypertension
Eligibility:
All Genders
60-90 years
Phase:
PHASE4
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 trea...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT00264212
Start Date
August 1 2004
Last Update
December 21 2007
Active Locations (8)
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1
Sanofi-Aventis
Santiago, Chile
2
Sanofi-Aventis
Shanghai, China
3
Sanofi-Aventis
Jakarta, Indonesia
4
Sanofi-Aventis
México, Mexico