ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Irbesartan - Hydrochlorothiazide (Drug); Irbesartan - Hydrochlorothiazide (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Nathalie - GENES, MD, Study Director, Affiliation: Sanofi-Aventis
Overall contact:
Public Registry GMA, Email: publicregistrygma@sanofi-aventis.com
Summary
To compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide
(HCTZ) using either a usual or an active elective titration regimen. The main efficacy
criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's
office with an automatic device, after a 10-week treatment period in hypertensive patients
insufficiently controlled by monotherapy.
Clinical Details
Official title: A Comparison of Active and Usual Titration Regimen in the Treatment of Hypertensive Patients Insufficiently Controlled by Monotherapy. A Randomised, Open-Label, Multicentre, Phase IIIb/IV Study
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in mean Systolic Blood Pressure
Secondary outcome: Change in mean Diastolic Blood Pressure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Established essential hypertension treated for at least 4 weeks by one
antihypertensive drug alone
- With uncontrolled Blood Pressure (BP) defined as:
- SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg in non diabetic patients
- SBP ≥ 150 mmHg and/or DBP ≥ 90 mmHg in diabetic patients
Exclusion Criteria:
- SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at V1
- Known or suspected causes of secondary hypertension
- Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary
kidney; history of renal transplant or only has one functioning kidney
- Associated cardiovascular conditions that prevent the patient from stopping the
current antihypertensive drug (e. g.: Beta-blocker for angina, ACE-inhibitors for heart
failure, etc…).
- Known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough
related to the administration of an angiotensin II receptor antagonist or any
combination of the drugs used
- Known contraindications to the study drugs:
- Severe renal dysfunction (creatinine clearance <30ml/min)
- Known hypokaliemia (< 3 mmol/L) , known hypercalcemia
- Severe hepatic impairment, biliary cirrhosis, cholestasis
- Inability to obtain a valid automatic BP measurement recording
- Administration of any other investigational drug within 30 days prior to study entry
and during the course of the study
- 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
the subject.
- Presence of any other conditions (e. g. geographic, social, etc) that would restrict or
limit the subject participation for the duration of the study.
- Pregnant or breast-feeding women
- Women of childbearing potential not protected by effective contraceptive method of
birth control
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
Locations and Contacts
Public Registry GMA, Email: publicregistrygma@sanofi-aventis.com
Sanofi-Aventis, Alger, Algeria; Active, not recruiting
Sanofi-Aventis, Buenos Aires, Argentina; Recruiting
Sanofi-Aventis, Sao Paulo, Brazil; Recruiting
Sanofi-Aventis, Bogota, Colombia; Active, not recruiting
Sanofi-Aventis, COSTA RICA, Costa Rica; Not yet recruiting
Sanofi-Aventis, Quito, Ecuador; Recruiting
Sanofi-Aventis, CAIRO, Egypt; Not yet recruiting
Sanofi-Aventis, Guatemala City, Guatemala; Completed
Sanofi-Aventis, BEIRUT, Lebanon; Recruiting
Sanofi-Aventis, Mexico D.F., Mexico; Active, not recruiting
Sanofi-Aventis, Casablanca, Morocco; Recruiting
Sanofi-Aventis, Panama, Panama; Recruiting
Sanofi-Aventis, Lima, Peru; Not yet recruiting
Sanofi-Aventis, Jeddah, Saudi Arabia; Recruiting
Sanofi-Aventis, Mégrine, Tunisia; Recruiting
Sanofi-Aventis, Dubai, United Arab Emirates; Recruiting
Sanofi-Aventis, Caracas, Venezuela; Recruiting
Additional Information
Starting date: June 2008
Last updated: February 2, 2009
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