Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy I-COMBINE

Not Applicable

• Conditions: -I10 Essential (primary) hypertension; Essential (primary) hypertension; I10

• Registration Number: PER-008-09
• Lead Sponsor: sanofi-aventis Recherche & Development,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Men and women> 18 years old
• Essential hypertension established
• Treated with amlodipine 5 mg monotherapy for at least 4 weeks
• With uncontrolled blood pressure defined as mean SBP> 145 mmHg evaluated by OBPM
• Signed informed consent obtained before inclusion in the study

Exclusion Criteria

• Average SBP> 180 mmHg and / or average DBP> 110 mmHg measured in the doctor´s office at Visit 1
• Known or suspected causes of secondary hypertension
• Patients with bilateral arterial stenosis, renal artery stenosis in a solitary kidney, renal transplant or only a functioning kidney
• Known contraindications or hypersensitivity to either amlodipine or irbesartan or to the combination of both medications or history of angioedema related to the administration of an angiotensin II receptor antagonist or any combination of medications used.
• Type 1 diabetes known
• Known severe hepatic impairment [alanine aminotransferase (ALT) or aspaitan aminotransferase (AST)> 5 times the upper limit of normal or history of hepatic encephalopathy, esophageal varices, or portocaval derivation]
• Known severe renal impairment (creatinine clearance <30 ml / mn)
• Concomitant use of any antihypertensive treatment
• Administration of any other investigative medication within 30 days prior to inclusion
• Inability to obtain a valid automatic blood pressure measurement record
• Presence of any severe medical or psychological condition that, in the opinion of the researcher, indicates that participation in the study is not in the best interest of the patient
• Presence of any condition (eg geographic, social, etc.) that could restrict or limit patient participation for the duration of the study
• Pregnant or breastfeeding women
• Women with the potential to conceive children who are incapable or who do not wish to use an acceptable method to prevent pregnancy during the entire study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified