AMISH : Aprovel for Management of Isolated Systolic Hypertension

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264212
• Other study ID #: R_8791
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2005
• Last updated: December 17, 2007
• Start date: August 2004

Study information

• Verified date: December 2007
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia : National Agency of Drug and Food Control (NA-DFC)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• irbesartan and irbesartan-hydrochlorothiazide

Locations

Country	Name	City	State
Chile	Sanofi-Aventis	Santiago
China	Sanofi-Aventis	Shangai
Indonesia	Sanofi-Aventis	Jakarta
Korea, Republic of	Sanofi-Aventis	Seoul
Mexico	Sanofi-Aventis	Mexico
Philippines	Sanofi-Aventis	Manila
Taiwan	Sanofi-Aventis	Taipei
Thailand	Sanofi-Aventis	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Bristol-Myers Squibb

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in office seated SBP at week 12
Secondary	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