AMISH : Aprovel for Management of Isolated Systolic Hypertension

Sanofi

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: irbesartan and irbesartan-hydrochlorothiazide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00264212

R_8791

Details and patient eligibility

About

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.

Sex

All

Ages

60 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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