AMISH : Aprovel for Management of Isolated Systolic Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00264212
• Date of registration: 09/12/2005
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: AMISH : Aprovel for Management of Isolated Systolic Hypertension
• Scientific 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
• Date of first enrolment: August 2004
• Target sample size: 436
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00264212
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Chile, China, Indonesia, Korea, Republic of, Mexico, Philippines, Taiwan, Thailand

Contacts

• Name: Pascale BLONDIN, MD
• Affiliation: Sanofi

Key inclusion & 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

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



Age minimum: 60 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Drug: irbesartan and irbesartan-hydrochlorothiazide

Primary Outcome(s)

Change from baseline in office seated SBP at week 12

Secondary Outcome(s)

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

Secondary ID(s)

R_8791

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb