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

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.


Condition Intervention Phase
Hypertension
Drug: Irbesartan - Hydrochlorothiazide
Phase IV

Study Type: Interventional
Study Design: Allocation: Randomized
Control: Uncontrolled
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Change in mean Systolic Blood Pressure [ Time Frame: between Visit 1 (Week 0) and Visit 4 (Week 10) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in mean Diastolic Blood Pressure [ Time Frame: between Visit 1 (Week 0) and Visit 4 (Week 10) ] [ Designated as safety issue: No ]

Enrollment: 832
Study Start Date: June 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1: Active Comparator
Usual elective titration regimen
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
Group 2: Active Comparator
Active elective titration regimen
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708344

Locations
Algeria
Sanofi-Aventis Administrative Office
Alger, Algeria
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Colombia
Sanofi-Aventis Administrative Office
Bogota, Colombia
Ecuador
Sanofi-Aventis Administrative Office
Quito, Ecuador
Egypt
Sanofi-Aventis Administrative Office
Cairo, Egypt
Guatemala
Sanofi-Aventis Administrative Office
Guatemala City, Guatemala
Lebanon
Sanofi-Aventis Administrative Office
Beirut, Lebanon
Mexico
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Morocco
Sanofi-Aventis Administrative Office
Casablanca, Morocco
Panama
Sanofi-Aventis Administrative Office
Panama, Panama
Peru
Sanofi-Aventis Administrative Office
Lima, Peru
Saudi Arabia
Sanofi-Aventis Administrative Office
Jeddah, Saudi Arabia
Tunisia
Sanofi-Aventis Administrative Office
Megrine, Tunisia
United Arab Emirates
Sanofi-Aventis Administrative Office
Dubaï, United Arab Emirates
Venezuela
Sanofi-Aventis Administrative Office
Caracas, Venezuela
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Nathalie - GENES, MD Sanofi-Aventis
  More Information

No publications provided

Responsible Party: sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers: IRBEH_R_02931
Study First Received: June 27, 2008
Last Updated: September 24, 2009
ClinicalTrials.gov Identifier: NCT00708344     History of Changes
Health Authority: Colombia: Institutional Review Board

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Irbesartan
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on March 18, 2010