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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01625494
First received: June 19, 2012
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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.

Condition Intervention Phase
Hypertension
 Drug: Irbesartan/Amlodipine (150/5mg)
Drug: Irbesartan/Amlodipine (150/10mg)
Drug: Irbesartan/Amlodipine (300/5mg)
Drug: Irbesartan/Amlodipine (300/10mg)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Open-label Multicentre Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg or Amlodipine 5 mg Monotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Proportion of patients with controlled OBPM (SBP<140 mmHg and DBP<90 mmHg) at the end of the study [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with controlled OBPM by visit and treatment group [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
    at Visit 3 (Week 8), at Visit 4 (Week 12) and at Visit 5 (Week 16)

  • Mean change in OBPM between 2 visits [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
    Visit 2 (Week 4) and Visit 5 (Week 16), Visit 2 (Week 4) and Visit 4 (week 12), Visit 2 (Week 4) and Visit 5 (Week 16), Visit 3 (Week 8) and Visit 4 (Week 12), Visit 3 (Week 8) and Visit 5 (Week 16)

  • Number of patients with adverse events [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients who discontinue from the study due to adverse events [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with abnormal liver function [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]
    As measured by AST, ALT, total bilirubin and serum creatinine


Enrollment: 158
Study Start Date: May 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

 Drug: Irbesartan/Amlodipine (150/5mg)
Pharmaceutical form: tablet Route of administration: oral
Experimental: Irbesartan/Amlodipine 150/10 mg fixed combination
1 tablet once daily in the morning for 4 weeks
 Drug: Irbesartan/Amlodipine (150/10mg)
Pharmaceutical form: tablet Route of administration: oral
Experimental: Irbesartan/Amlodipine 300/5 mg fixed combination
1 tablet once daily in the morning for 4 weeks
 Drug: Irbesartan/Amlodipine (300/5mg)
Pharmaceutical form: tablet Route of administration: oral
Experimental: 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
 Drug: Irbesartan/Amlodipine (300/10mg)
Pharmaceutical form:tablet Route of administration: oral

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625494

Locations
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01625494     History of Changes
Other Study ID Numbers: IRBES_L_05887, U1111-1117-9116
Study First Received: June 19, 2012
Last Updated: January 17, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Irbesartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 19, 2013