Clinical trial NCT00264212: AMISH : Aprovel for Management 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-12-12
Enrollment: 436
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in office seated SBP at week 12
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Sanofi-Aventis
city: Shangai
country: China
facility: Sanofi-Aventis
city: Jakarta
country: Indonesia
facility: Sanofi-Aventis
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis
city: Mexico
country: Mexico
facility: Sanofi-Aventis
city: Manila
country: Philippines
facility: Sanofi-Aventis
city: Taipei
country: Taiwan
facility: Sanofi-Aventis
city: Bangkok
country: Thailand
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Pascale BLONDIN, MD
role: STUDY_DIRECTOR
References: