Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy

NCT00957554 | Completed Phase 3

• 1 other identifier: IRBAM_R_04219
• Study Type: interventional
• Target: 435
• Locations: 8 countries
• Sites: 38

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean home systolic blood pressure

  At randomisation and week 10

Secondary Outcomes (2)

• Mean office blood pressure

  At randomisation, week 5 and week 10

• Mean home diastolic blood pressure

  At randomisation, week 5 and week 10

Study Arms (2)

irbesartan/amlodipine

EXPERIMENTAL

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

Drug: irbesartan/amlodipine

irbesartan

ACTIVE COMPARATOR

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

Drug: irbesartan

Interventions

irbesartan/amlodipine DRUG

Pharmaceutical form: 150/5 mg and 150/10 mg tablets (fixed combination) Route of administration: oral Dose regimen: 1 tablet once daily

irbesartan/amlodipine

irbesartan DRUG

Pharmaceutical form: 150 and 300 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily

irbesartan

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (38)

Sanofi-Aventis Investigational Site Number 07605

Belo Horizonte, 30150-221, Brazil

Location

Sanofi-Aventis Investigational Site Number 07602

Caxias do Sul, 95070-560, Brazil

Location

Sanofi-Aventis Investigational Site Number 07604

Maceió, 57051-500, Brazil

Location

Sanofi-Aventis Investigational Site Number 07603

São José do Rio Preto, 15015-210, Brazil

Location

Sanofi-Aventis Investigational Site Number 07601

Sorocaba, 18030-083, Brazil

Location

Sanofi-Aventis Investigational Site Number 17001

Barranquilla, Colombia

Location

Sanofi-Aventis Investigational Site Number 17002

Barranquilla, Colombia

Location

Sanofi-Aventis Investigational Site Number 17003

Cartagena, Colombia

Location

Sanofi-Aventis Investigational Site Number 32001

Guatemala City, Guatemala

Location

Sanofi-Aventis Investigational Site Number 32002

Guatemala City, Guatemala

Location

Sanofi-Aventis Investigational Site Number 32003

Guatemala City, Guatemala

Location

Sanofi-Aventis Investigational Site Number 32004

Guatemala City, Guatemala

Location

Sanofi-Aventis Investigational Site Number 32005

Guatemala City, Guatemala

Location

Sanofi-Aventis Investigational Site Number 48402

Guadalajara, 44340, Mexico

Location

Sanofi-Aventis Investigational Site Number 48401

Mérida, 97070, Mexico

Location

Sanofi-Aventis Investigational Site Number 48406

México, 11340, Mexico

Location

Sanofi-Aventis Investigational Site Number 48403

San Luis Potosí City, 72244, Mexico

Location

Sanofi-Aventis Investigational Site Number 48407

San Luis Potosí City, 78200, Mexico

Location

Sanofi-Aventis Investigational Site Number 48404

Torreón, 27000, Mexico

Location

Sanofi-Aventis Investigational Site Number 48408

Zapopan, 44210, Mexico

Location

Sanofi-Aventis Investigational Site Number 50403

Casablanca, 20000, Morocco

Location

Sanofi-Aventis Investigational Site Number 50401

Casablanca, Morocco

Location

Sanofi-Aventis Investigational Site Number 50402

Casablanca, Morocco

Location

Sanofi-Aventis Investigational Site Number 50405

Casablanca, Morocco

Location

Sanofi-Aventis Investigational Site Number 50404

Rabat, Morocco

Location

Sanofi-Aventis Investigational Site Number 50406

Rabat, Morocco

Location

Sanofi-Aventis Investigational Site Number 78805

Aryanah, Tunisia

Location

Sanofi-Aventis Investigational Site Number 78804

La Marsa, Tunisia

Location

Sanofi-Aventis Investigational Site Number 78802

Menzel Bourguiba, Tunisia

Location

Sanofi-Aventis Investigational Site Number 78813

Monastir, 5000, Tunisia

Location

Sanofi-Aventis Investigational Site Number 78815

Sousse, Tunisia

Location

Sanofi-Aventis Investigational Site Number 78801

Tunis, 1008, Tunisia

Location

Sanofi-Aventis Investigational Site Number 78812

Tunis, 1008, Tunisia

Location

Sanofi-Aventis Investigational Site Number 78803

Tunis, Tunisia

Location

Sanofi-Aventis Investigational Site Number 78807

Tunis, Tunisia

Location

Sanofi-Aventis Investigational Site Number 784-001

Abu Dhabi, United Arab Emirates

Location

Sanofi-Aventis Investigational Site Number 784-02

Dubai, 4545, United Arab Emirates

Location

Sanofi-Aventis Investigational Site Number 86201

Maracaibo, Venezuela

Location

Related Publications (1)

• Bobrie G; I-ADD Study Investigators. I-ADD study: assessment of efficacy and safety profile of irbesartan/amlodipine fixed-dose combination therapy compared with irbesartan monotherapy in hypertensive patients uncontrolled with irbesartan 150 mg monotherapy: a multicenter, phase III, prospective, randomized, open-label with blinded-end point evaluation study. Clin Ther. 2012 Aug;34(8):1720-34.e3. doi: 10.1016/j.clinthera.2012.07.001. Epub 2012 Jul 30.

  PMID: 22853847 DERIVED

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

• Nathalie Genes, MD

  Sanofi

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 12, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 26, 2010

Record last verified: 2010-10

Locations

ME (7); VE (1); BR (5); TU (9); CO (3); GU (5); AE (2); MO (6)