Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Irbesartan/Amlodipine (150/10mg); Drug: Irbesartan/Amlodipine (150/5mg); Drug: Irbesartan/Amlodipine (300/5mg); Drug: Irbesartan/Amlodipine (300/10mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01625494

IRBES_L_05887

U1111-1117-9116 (Other Identifier)

Details and patient eligibility

About

Primary Objective:

• To assess the proportion of patients with controlled Office Blood Pressure Measurements (OBPM), defined as Systolic blood pressure < 140 mmHg and Diastolic blood pressure <90mmHg, at the end of the study

Secondary Objectives:

• To examine over time the antihypertensive effect of the 4 doses of the fixed combination therapy irbesartan/amlodipine on OBPM (SBP (systolic blood pressure) and DBP (diastolic blood pressure)
• To examine the proportion of patients with controlled OBPM (systolic BP<140 mm Hg and diastolic BP<90 mmHg) of the different dose groups over time
• To determine the incidence and severity of adverse events.

Full description

16 weeks

• V1 (week 0): Inclusion visit.
• V2 (Week 4): Irbesartan/amlodipine 150/5 mg fixed combination visit
• V3 (Week 8): 1st dose escalation for patients in whom OBPM is not controlled (SBP ≥ 140 mmHg or DBP ≥ 90mmHg,
• V4 (Week 12): 2nd Dose escalation visit for patients in whom OBPM is not controlled (SBP ≥ 140 mmHg or DBP ≥ 90mmHg
• V5 (Week 16): End of study visit

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

• Men and women ≥18 years old
• Established essential hypertension
• Treated with irbesartan 150 mg or amlodipine 5 mg as monotherapy for at least 2 weeks
• With uncontrolled systolic BP (blood pressure) defined as ≥140 mm Hg assessed by OBPM (office blood pressure measurements)
• Signed written informed consent obtained prior to inclusion to the study

Exclusion criteria:

• Mean systolic BP ≥180 mm Hg and/or mean diastolic BP ≥110 mm Hg by OBPM on 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
• Known contraindications or hypersensitivity to either amlodipine or irbesartan or to the combination
• History of angioedema related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
• Severe hepatic impairment (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >5 times the upper normal limit (ULN) or history of hepatic encephalopathy, esophageal varices or portocaval shunt)
• Severe renal impairment (glomerular filtration rate <30 ml/min)
• Concomitant use of any other antihypertensive treatment except of Irbesartan and Amlodipine
• Administration of any other investigational drug within 30 days before inclusion
• Presence of any other conditions 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
• Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol

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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158 participants in 4 patient groups

Irbesartan/Amlodipine 150/5 mg fixed combination

Experimental group

Description:

1 tablet once daily in the morning for 4 weeks Patient will be first treated with irbesartan 150mg or amlodipine 5mg, 1 tablet /day for 4 weeks. If OBPM is controlled on monotherapy at week 4 (SBP \<140 mmHg and DBP\<90 mmHg), patient will be withdrawn from the study

Treatment:

Drug: Irbesartan/Amlodipine (150/5mg)

Irbesartan/Amlodipine 150/10 mg fixed combination

Experimental group

Description:

1 tablet once daily in the morning for 4 weeks

Treatment:

Drug: Irbesartan/Amlodipine (150/10mg)

Irbesartan/Amlodipine 300/5 mg fixed combination

Experimental group

Description:

1 tablet once daily in the morning for 4 weeks

Treatment:

Drug: Irbesartan/Amlodipine (300/5mg)

Irbesartan/Amlodipine 300/10 mg fixed combination

Experimental group

Description:

1 tablet once daily in the morning for 4 weeks. If OBPM is controlled at week 12, patients will continue on the same therapy until the end of the study

Treatment:

Drug: Irbesartan/Amlodipine (300/10mg)