Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy (I-ADD)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: irbesartan; Drug: irbesartan/amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00957554

IRBAM_R_04219

Details and patient eligibility

About

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

Enrollment: 435 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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435 participants in 2 patient groups

irbesartan/amlodipine

Experimental group

Description:

Before randomisation: irbesartan 150 mg for 7 to 10 days (common in the 2 arms) then After randomisation: irbesartan/amlodipine 150/5 mg fixed combination for 5 weeks followed by irbesartan/amlodipine 300/5 mg fixed combination for additional 5 weeks

Treatment:

Drug: irbesartan/amlodipine

irbesartan

Active Comparator group

Description:

Before randomisation: irbesartan 150 mg for 7 to 10 days (common in the 2 arms) then After randomisation: irbesartan 150 mg for 5 weeks followed by irbesartan 300 mg for 5 additional weeks

Treatment:

Drug: irbesartan