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Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension

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: NCT00095394
Recruitment Status : Completed
First Posted : November 4, 2004
Last Update Posted : April 15, 2011
Sponsor:
Collaborator:
Sanofi
Information provided by:
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this clinical research is to learn if severe hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Irbesartan/HCTZ Drug: Irbesartan monotherapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 645 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Severe Hypertension
Study Start Date : September 2004
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

Arms and Interventions
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Arm Intervention/treatment
Experimental: A1 Drug: Irbesartan/HCTZ
Tablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.
Other Name: Avapro
Active Comparator: A2 Drug: Irbesartan monotherapy
Tablets, Oral, 150 mg, Once daily, 7 weeks.
Other Name: Avapro


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5

Secondary Outcome Measures :
  1. Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 17 weeks of therapy.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ages 18 and older;
  • Willing to provide written informed consent;
  • Must have uncontrolled hypertension defined as: currently untreated with a diastolic blood pressure greater than 110 mmHg OR currently receiving antihypertensive monotherapy with a diastolic blood pressure greater than 100 mmHg. Monotherapy is defined as treatment with one antihypertensive medication for at least four weeks; fixed combination therapy does not represent monotherapy;
  • Must be willing to discontinue antihypertensive medication, if applicable;
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to one week after the study in such a manner that the risk of pregnancy is minimized.
  • WOCBP must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding;
  • Known or suspected secondary hypertension;
  • Hypertension emergencies or stroke within the past 12 months;
  • Heart attack, angina or bypass surgery within the past 6 months;
  • Significant kidney disease;
  • Significant liver disease;
  • Systemic lupus erythematosus;
  • Gastrointestinal disease or surgery that may interfere with drug absorption;
  • Cancer during the past five years excluding localized squamous cell or basal cell carcinoma of the skin;
  • Currently pregnant or lactating;
  • Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the study;
  • Drug or alcohol abuse within the last five years;
  • Known allergy to irbesartan or diuretics.
Contacts and Locations
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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): NCT00095394


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Sanofi
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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ClinicalTrials.gov Identifier: NCT00095394    
Other Study ID Numbers: CV131-176
First Posted: November 4, 2004    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: August 2008
Keywords provided by Bristol-Myers Squibb:
Severe Hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Irbesartan
 Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action