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

NCT01625494 | Completed Phase 3

• 2 other identifiers: IRBES_L_05887U1111-1117-9116
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with controlled OBPM (SBP<140 mmHg and DBP<90 mmHg) at the end of the study

  up to 16 weeks

Secondary Outcomes (5)

• Proportion of patients with controlled OBPM by visit and treatment group

  up to 16 weeks

• Mean change in OBPM between 2 visits

  up to 16 weeks

• Number of patients with adverse events

  up to 16 weeks

• Number of patients who discontinue from the study due to adverse events

  up to 16 weeks

• Number of patients with abnormal liver function

  up to 16 weeks

Study Arms (4)

Irbesartan/Amlodipine 150/5 mg fixed combination

EXPERIMENTAL

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90 mmHg), patient will be withdrawn from the study

Drug: Irbesartan/Amlodipine (150/5mg)

Irbesartan/Amlodipine 150/10 mg fixed combination

EXPERIMENTAL

1 tablet once daily in the morning for 4 weeks

Drug: Irbesartan/Amlodipine (150/10mg)

Irbesartan/Amlodipine 300/5 mg fixed combination

EXPERIMENTAL

1 tablet once daily in the morning for 4 weeks

Drug: Irbesartan/Amlodipine (300/5mg)

Irbesartan/Amlodipine 300/10 mg fixed combination

EXPERIMENTAL

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

Drug: Irbesartan/Amlodipine (300/10mg)

Interventions

Irbesartan/Amlodipine (150/5mg) DRUG

Pharmaceutical form: tablet Route of administration: oral

Irbesartan/Amlodipine 150/5 mg fixed combination

Irbesartan/Amlodipine (150/10mg) DRUG

Pharmaceutical form: tablet Route of administration: oral

Irbesartan/Amlodipine 150/10 mg fixed combination

Irbesartan/Amlodipine (300/5mg) DRUG

Pharmaceutical form: tablet Route of administration: oral

Irbesartan/Amlodipine 300/5 mg fixed combination

Irbesartan/Amlodipine (300/10mg) DRUG

Pharmaceutical form:tablet Route of administration: oral

Irbesartan/Amlodipine 300/10 mg fixed combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Moscow, Russia

Location

MeSH Terms

Conditions

Hypertension

Interventions

Irbesartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Dihydropyridines; Pyridines

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 18, 2013

Record last verified: 2013-01

Locations

RU (1)