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ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination
This study has been completed.
Study NCT00708344   Information provided by Sanofi-Aventis
First Received: June 27, 2008   Last Updated: September 24, 2009   History of Changes

June 27, 2008
September 24, 2009
June 2008
July 2009   (final data collection date for primary outcome measure)
Change in mean Systolic Blood Pressure [ Time Frame: between Visit 1 (Week 0) and Visit 4 (Week 10) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00708344 on ClinicalTrials.gov Archive Site
Change in mean Diastolic Blood Pressure [ Time Frame: between Visit 1 (Week 0) and Visit 4 (Week 10) ] [ Designated as safety issue: No ]
Same as current
 
ACTUAL: 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. A Randomised, Open-label, Multicentre, Phase IIIb/IV Study

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.

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Hypertension
  • Drug: Irbesartan - Hydrochlorothiazide
    150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Duration of treatment : 10 weeks
  • Drug: Irbesartan - Hydrochlorothiazide
    150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Treatment duration : 10 weeks
  • Group 1: Active Comparator
    Usual elective titration regimen
    Intervention: Drug: Irbesartan - Hydrochlorothiazide
  • Group 2: Active Comparator
    Active elective titration regimen
    Intervention: Drug: Irbesartan - Hydrochlorothiazide
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
832
July 2009
July 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Algeria,   Argentina,   Brazil,   Colombia,   Ecuador,   Egypt,   Guatemala,   Lebanon,   Mexico,   Morocco,   Panama,   Peru,   Saudi Arabia,   Tunisia,   United Arab Emirates,   Venezuela
 
NCT00708344
Medical Affairs Study Director, sanofi-aventis
IRBEH_R_02931
Sanofi-Aventis
 
Study Director: Nathalie - GENES, MD Sanofi-Aventis
Sanofi-Aventis
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP