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

Hypertension Clinical Trial

— I-ADD  

Official title:

Efficacy and Safety of Irbesartan/Amlodipine Fixed Combination Therapy Compared With Irbesartan Monotherapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957554
• Other study ID #: IRBAM_R_04219
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2009
• Last updated: October 25, 2010
• Start date: July 2009
• Est. completion date: September 2010

Study information

• Verified date: October 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• 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

• Signed written inform consent obtained prior to inclusion in the study

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

Exclusion criteria:

• 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

• Administration of any other investigational drug within 30 days before inclusion

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• irbesartan/amlodipine
Pharmaceutical form: 150/5 mg and 150/10 mg tablets (fixed combination) Route of administration: oral Dose regimen: 1 tablet once daily
• irbesartan
Pharmaceutical form: 150 and 300 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Investigational Site Number 07605	Belo Horizonte
Brazil	Sanofi-Aventis Investigational Site Number 07602	Caxias do Sul
Brazil	Sanofi-Aventis Investigational Site Number 07604	Maceió
Brazil	Sanofi-Aventis Investigational Site Number 07603	São José do Rio Preto
Brazil	Sanofi-Aventis Investigational Site Number 07601	Sorocaba
Colombia	Sanofi-Aventis Investigational Site Number 17001	Barranquilla
Colombia	Sanofi-Aventis Investigational Site Number 17002	Barranquilla
Colombia	Sanofi-Aventis Investigational Site Number 17003	Cartagena
Guatemala	Sanofi-Aventis Investigational Site Number 32001	Guatemala
Guatemala	Sanofi-Aventis Investigational Site Number 32002	Guatemala
Guatemala	Sanofi-Aventis Investigational Site Number 32003	Guatemala
Guatemala	Sanofi-Aventis Investigational Site Number 32004	Guatemala
Guatemala	Sanofi-Aventis Investigational Site Number 32005	Guatemala
Mexico	Sanofi-Aventis Investigational Site Number 48402	Guadalajara
Mexico	Sanofi-Aventis Investigational Site Number 48401	Mérida
Mexico	Sanofi-Aventis Investigational Site Number 48406	Mexico
Mexico	Sanofi-Aventis Investigational Site Number 48403	San Luis Potosi
Mexico	Sanofi-Aventis Investigational Site Number 48407	San Luis Potosi
Mexico	Sanofi-Aventis Investigational Site Number 48404	Torreon
Mexico	Sanofi-Aventis Investigational Site Number 48408	Zapopan
Morocco	Sanofi-Aventis Investigational Site Number 50401	Casablanca
Morocco	Sanofi-Aventis Investigational Site Number 50402	Casablanca
Morocco	Sanofi-Aventis Investigational Site Number 50403	Casablanca
Morocco	Sanofi-Aventis Investigational Site Number 50405	Casablanca
Morocco	Sanofi-Aventis Investigational Site Number 50404	Rabat
Morocco	Sanofi-Aventis Investigational Site Number 50406	Rabat
Tunisia	Sanofi-Aventis Investigational Site Number 78805	Ariana
Tunisia	Sanofi-Aventis Investigational Site Number 78804	La marsa
Tunisia	Sanofi-Aventis Investigational Site Number 78802	Menzel Bourguiba
Tunisia	Sanofi-Aventis Investigational Site Number 78813	Monastir
Tunisia	Sanofi-Aventis Investigational Site Number 78815	Sousse
Tunisia	Sanofi-Aventis Investigational Site Number 78801	Tunis
Tunisia	Sanofi-Aventis Investigational Site Number 78803	Tunis
Tunisia	Sanofi-Aventis Investigational Site Number 78807	Tunis
Tunisia	Sanofi-Aventis Investigational Site Number 78812	Tunis
United Arab Emirates	Sanofi-Aventis Investigational Site Number 784-001	Abu Dhabi
United Arab Emirates	Sanofi-Aventis Investigational Site Number 784-02	Dubai
Venezuela	Sanofi-Aventis Investigational Site Number 86201	Maracaibo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Brazil,  Colombia,  Guatemala,  Mexico,  Morocco,  Tunisia,  United Arab Emirates,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean home systolic blood pressure		At randomisation and week 10	No
Secondary	Mean office blood pressure		At randomisation, week 5 and week 10	No
Secondary	Mean home diastolic blood pressure		At randomisation, week 5 and week 10	No