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ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination
This study is currently recruiting participants.
Verified by Sanofi-Aventis, December 2008
Sponsored by: 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

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Hydrochlorothiazide Irbesartan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment: 834
Study Start Date: June 2008
Estimated Primary Completion Date: April 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

Contacts
Contact: Public Registry GMA publicregistrygma@sanofi-aventis.com

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Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Nathalie - GENES, MD Sanofi-Aventis
  More Information

Responsible Party: sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers: IRBEH_R_02931
Study First Received: June 27, 2008
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00708344  
Health Authority: Colombia: Institutional Review Board

Study placed in the following topic categories:
Irbesartan
Vascular Diseases
Angiotensin II
Hydrochlorothiazide
Hypertension

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

ClinicalTrials.gov processed this record on January 16, 2009