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”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: irbesartan and irbesartan-hydrochlorothiazide

Primary Measures

• Change from baseline in office seated SBP at week 12

Secondary Measures

• 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Pascale BLONDIN, MD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00264212

Study ID Number: R_8791

ClinicalTrials.gov Identifier: NCT00264212

Health Authority: Indonesia : National Agency of Drug and Food Control (NA-DFC)

Link to CSR.org (study results)