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ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination (ACTUAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00708344
Recruitment Status : Completed
First Posted : July 2, 2008
Last Update Posted : July 16, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Irbesartan - Hydrochlorothiazide Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 832 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2008
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Group 1
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
Active Comparator: Group 2
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


Outcome Measures

Primary Outcome Measures :
  1. Change in mean Systolic Blood Pressure [ Time Frame: between Visit 1 (Week 0) and Visit 4 (Week 10) ]

Secondary Outcome Measures :
  1. Change in mean Diastolic Blood Pressure [ Time Frame: between Visit 1 (Week 0) and Visit 4 (Week 10) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708344


Locations
Algeria
Sanofi-Aventis Administrative Office
Algiers, 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
Investigators
Study Director: Nathalie - GENES, MD Sanofi
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00708344     History of Changes
Other Study ID Numbers: IRBEH_R_02931
First Posted: July 2, 2008    Key Record Dates
Last Update Posted: July 16, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Irbesartan
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists