Clinical trial NCT00708344: ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination
Official title: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination: A Comparison of Active and Usual Titration Regimen in the Treatment of Hypertensive Patients Insufficiently Controlled by Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 832
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change in mean Systolic Blood Pressure
timeFrame: between Visit 1 (Week 0) and Visit 4 (Week 10)
Secondary outcomes:
measure: Change in mean Diastolic Blood Pressure
timeFrame: between Visit 1 (Week 0) and Visit 4 (Week 10)
Other outcomes:
Locations:
city: Algiers
country: Algeria
facility: Sanofi-Aventis Administrative Office
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis Administrative Office
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
city: Bogota
country: Colombia
facility: Sanofi-Aventis Administrative Office
city: Quito
country: Ecuador
facility: Sanofi-Aventis Administrative Office
city: Cairo
country: Egypt
facility: Sanofi-Aventis Administrative Office
city: Guatemala City
country: Guatemala
facility: Sanofi-Aventis Administrative Office
city: Beirut
country: Lebanon
facility: Sanofi-Aventis Administrative Office
city: Col. Coyoacan
country: Mexico
facility: Sanofi-Aventis Administrative Office
city: Casablanca
country: Morocco
facility: Sanofi-Aventis Administrative Office
city: Panama
country: Panama
facility: Sanofi-Aventis Administrative Office
city: Lima
country: Peru
facility: Sanofi-Aventis Administrative Office
city: Jeddah
country: Saudi Arabia
facility: Sanofi-Aventis Administrative Office
city: Megrine
country: Tunisia
facility: Sanofi-Aventis Administrative Office
city: Dubaï
country: United Arab Emirates
facility: Sanofi-Aventis Administrative Office
city: Caracas
country: Venezuela
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Nathalie - GENES, MD
role: STUDY_DIRECTOR
References:
citation: Girerd X, Rosenbaum D, Aoun J; ACTUAL study Investigators. Efficacy and safety of early versus late titration of fixed-dose irbesartan/hydrochlorothiazide: ACTUAL study. Blood Press Suppl. 2011 Dec;2:22-9. doi: 10.3109/08037051.2011.633368.