AMISH : Aprovel for Management of Isolated Systolic Hypertension

Condition(s) targeted: Hypertension

Intervention: irbesartan and irbesartan-hydrochlorothiazide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Pascale BLONDIN, MD, Study Director, Affiliation: Sanofi-Aventis

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in office seated SBP at week 12

Secondary outcome: 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

Minimum age: 60 Years. Maximum age: 90 Years. Gender(s): Both.

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.

Sanofi-Aventis, SANTIAGO, Chile

Sanofi-Aventis, SHANGAI, China

Sanofi-Aventis, JAKARTA, Indonesia

Sanofi-Aventis, SEOUL, Korea, Republic of

Sanofi-Aventis, MEXICO, Mexico

Sanofi-Aventis, MANILA, Philippines

Sanofi-Aventis, TAIPEI, Taiwan

Sanofi-Aventis, BANGKOK, Thailand

Link to CSR.org (study results)

Starting date: August 2004
Last updated: December 17, 2007