Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy

Condition(s) targeted: Hypertension

Intervention: irbesartan/amlodipine (Drug); irbesartan (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sanofi-Aventis

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

Overall contact:
For site information, send an email with site number to, Email: PublicRegistryGMA@sanofi-aventis.com

Primary Objective:

To demonstrate that the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 300/5 mg is superior to that of irbesartan 300 mg monotherapy in lowering systolic blood pressure (SBP) as measured by home blood pressure measurement (HBPM) after 10 weeks of treatment (W10)

Secondary Objective:

- To compare the antihypertensive efficacy of the fixed combination irbesartan/amlodipine

300/5 mg with that of irbesartan 300 mg monotherapy after 10 weeks of treatment (W10)

- To compare the antihypertensive efficacy of the fixed combination therapy

irbesartan/amlodipine 150/5 mg with that of irbesartan 150 mg monotherapy after 5 weeks of treatment (W5)

- To examine in each treatment group the change from week 5 to week 10 in SBP and

diastolic blood pressure (DBP) assessed by HBPM and by office blood pressure measurement (OBPM)

- To determine the incidence and severity of adverse events

Official title: Efficacy and Safety of Irbesartan/Amlodipine Fixed Combination Therapy Compared With Irbesartan Monotherapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy

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

Primary outcome: Mean home systolic blood pressure

Secondary outcome:

Mean office blood pressure

Mean home diastolic blood pressure

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- Established essential hypertension

- Treated with irbesartan 150 mg monotherapy for at least 4 weeks

- With uncontrolled BP defined as mean SBP = or > 145 mmHg assessed by OBPM

- Signed written inform consent obtained prior to inclusion in the study

Randomisation Criteria:

- Mean SBP = or > 135 mmHg assessed by HBPM

- Good compliance with the HBPM protocol defined as at least 12 correct measurements

performed over the last 6 days of the first period of measurements

- Creatinine clearance = or > 30 ml/min determined ny Cockroft formula

Exclusion criteria:

- Mean SBP = or > 180 mmHg and/or mean DBP = or > 110 mmHg measured at doctor's office

at Visit 1

- Known or suspected causes of secondary hypertension

- Patients with bilateral artery stenosis, renal artery stenosis in a solitary kidney,

renal transplant or only has one functioning kidney

- Know contraindications or hypersensitivity to either amlodipine or irbesartan or to

the combination or history of angioedema related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used

- Know type 1 diabetes

- Know severe hepatic impairment alanine aminotransferase (ALT) or aspartate

aminotransferase (AST) > 5 times the upper limit of normal or history of hepatic encephalopathy, esophageal varices, or portocaval shunt

- Know severe renal impairment (creatinine clearance < 30 ml/mn)

- Concomitant use of any other antihypertensive treatment

- Administration of any other investigational drug within 30 days before inclusion

- Inability to obtain a valid automatic BP measurement recording

- Presence of any severe medical or psychological condition that, in the opinion of the

investigator, indicate that participation in the study is not in the best interest of of the patient

- Presence of any other conditions (e. g.: geographical, social, etc) that would

restrict or limit the patient participation for the duration of the study

- Pregnant or breast feeding women

- Women of childbearing potential unable or unwilling to use an acceptable method to

avoid pregnancy for the entire study period

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

For site information, send an email with site number to, Email: PublicRegistryGMA@sanofi-aventis.com

Sanofi-Aventis Investigational Site Number 07605, Belo Horizonte 30150-221, Brazil; Active, not recruiting

Sanofi-Aventis Investigational Site Number 07602, Caxias do Sul 95070-560, Brazil; Active, not recruiting

Sanofi-Aventis Investigational Site Number 07604, Maceió 57051-500, Brazil; Active, not recruiting

Sanofi-Aventis Investigational Site Number 07601, Sorocaba 18030-083, Brazil; Active, not recruiting

Sanofi-Aventis Investigational Site Number 07603, São José do Rio Preto 15015-210, Brazil; Not yet recruiting

Sanofi-Aventis Investigational Site Number 17002, Barranquilla, Colombia; Active, not recruiting

Sanofi-Aventis Investigational Site Number 17001, Barranquilla, Colombia; Active, not recruiting

Sanofi-Aventis Investigational Site Number 17003, Cartagena, Colombia; Active, not recruiting

Sanofi-Aventis Investigational Site Number 32001, Guatemala, Guatemala; Active, not recruiting

Sanofi-Aventis Investigational Site Number 32002, Guatemala, Guatemala; Active, not recruiting

Sanofi-Aventis Investigational Site Number 32003, Guatemala, Guatemala; Active, not recruiting

Sanofi-Aventis Investigational Site Number 32004, Guatemala, Guatemala; Active, not recruiting

Sanofi-Aventis Investigational Site Number 32005, Guatemala, Guatemala; Active, not recruiting

Sanofi-Aventis Investigational Site Number 48402, Guadalajara 44340, Mexico; Active, not recruiting

Sanofi-Aventis Investigational Site Number 48406, Mexico 11340, Mexico; Active, not recruiting

Sanofi-Aventis Investigational Site Number 48401, Mérida 97070, Mexico; Active, not recruiting

Sanofi-Aventis Investigational Site Number 48407, San Luis Potosi 78200, Mexico; Active, not recruiting

Sanofi-Aventis Investigational Site Number 48403, San Luis Potosi 72244, Mexico; Active, not recruiting

Sanofi-Aventis Investigational Site Number 48404, Torreon 27000, Mexico; Active, not recruiting

Sanofi-Aventis Investigational Site Number 48408, Zapopan 44210, Mexico; Active, not recruiting

Sanofi-Aventis Investigational Site Number 50401, Casablanca, Morocco; Recruiting

Sanofi-Aventis Investigational Site Number 50402, Casablanca, Morocco; Recruiting

Sanofi-Aventis Investigational Site Number 50405, Casablanca, Morocco; Not yet recruiting

Sanofi-Aventis Investigational Site Number 50403, Casablanca 20000, Morocco; Not yet recruiting

Sanofi-Aventis Investigational Site Number 50404, Rabat, Morocco; Recruiting

Sanofi-Aventis Investigational Site Number 50406, Rabat, Morocco; Recruiting

Sanofi-Aventis Investigational Site Number 78805, Ariana, Tunisia; Not yet recruiting

Sanofi-Aventis Investigational Site Number 78804, La marsa, Tunisia; Active, not recruiting

Sanofi-Aventis Investigational Site Number 78802, Menzel Bourguiba, Tunisia; Recruiting

Sanofi-Aventis Investigational Site Number 78813, Monastir 5000, Tunisia; Not yet recruiting

Sanofi-Aventis Investigational Site Number 78815, Sousse, Tunisia; Active, not recruiting

Sanofi-Aventis Investigational Site Number 78801, Tunis 1008, Tunisia; Active, not recruiting

Sanofi-Aventis Investigational Site Number 78803, Tunis, Tunisia; Active, not recruiting

Sanofi-Aventis Investigational Site Number 78807, Tunis, Tunisia; Active, not recruiting

Sanofi-Aventis Investigational Site Number 78812, Tunis 1008, Tunisia; Not yet recruiting

Sanofi-Aventis Investigational Site Number 784-001, Abu Dhabi, United Arab Emirates; Recruiting

Sanofi-Aventis Investigational Site Number 784-02, Dubai 4545, United Arab Emirates; Recruiting

Sanofi-Aventis Investigational Site Number 86201, Maracaibo, Venezuela; Not yet recruiting

Starting date: July 2009
Last updated: October 1, 2010