| 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
|
| |
| |
| 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 |