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

NCT ID: NCT01625494

Last Updated: 2013-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-01-31

Brief Summary

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.

Detailed 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

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Irbesartan/Amlodipine 150/5 mg fixed combination

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90 mmHg), patient will be withdrawn from the study

Group Type: EXPERIMENTAL

Irbesartan/Amlodipine (150/5mg)

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral

Irbesartan/Amlodipine 150/10 mg fixed combination

1 tablet once daily in the morning for 4 weeks

Group Type: EXPERIMENTAL

Irbesartan/Amlodipine (150/10mg)

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral

Irbesartan/Amlodipine 300/5 mg fixed combination

1 tablet once daily in the morning for 4 weeks

Group Type: EXPERIMENTAL

Irbesartan/Amlodipine (300/5mg)

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral

Irbesartan/Amlodipine 300/10 mg fixed combination

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

Group Type: EXPERIMENTAL

Irbesartan/Amlodipine (300/10mg)

Intervention Type: DRUG

Pharmaceutical form:tablet Route of administration: oral

Interventions

Irbesartan/Amlodipine (150/5mg)

Pharmaceutical form: tablet Route of administration: oral

Intervention Type: DRUG

Irbesartan/Amlodipine (150/10mg)

Pharmaceutical form: tablet Route of administration: oral

Intervention Type: DRUG

Irbesartan/Amlodipine (300/5mg)

Pharmaceutical form: tablet Route of administration: oral

Intervention Type: DRUG

Irbesartan/Amlodipine (300/10mg)

Pharmaceutical form:tablet Route of administration: oral

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Moscow, , Russia

Countries

Russia

Other Identifiers

U1111-1117-9116

Identifier Type: OTHER

Identifier Source: secondary_id

IRBES_L_05887

Identifier Type: -

Identifier Source: org_study_id