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Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension

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ClinicalTrials.gov Identifier: NCT00095550
Recruitment Status : Completed
First Posted : November 8, 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 moderate 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 Drug: HCTZ monotherapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 496 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 Patients With Moderate Hypertension
Study Start Date : October 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 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 150 mg/HCTZ 12.5 mg, Once daily, 12 weeks.
Other Name: Avapro
Active Comparator: A2 Drug: Irbesartan monotherapy
Tablets, Oral, 150 mg, Once daily, 12 weeks.
Other Name: Avapro
Active Comparator: A3 Drug: HCTZ monotherapy
Tablets, Oral, 12.5 mg, Once daily, 12 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in SeSBP at Week 8

Secondary Outcome Measures :
  1. Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 12 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:

  • Willing to provide written informed consent

  • Subjects must have uncontrolled hypertension defined as:

    • average systolic blood pressure between 160 mmHg and 180 mmHg (while diastolic blood pressure is less than 110 mmHg) or
    • average diastolic blood pressure between 100 mmHg and 110 mmHg (while systolic blood pressure is between 130 mmHg and 180 mmHg)
  • Subjects must be willing to discontinue their antihypertensive medication, if applicable.
  • Men and women, ages 18 and older will be included.
  • 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 six months.
  • Significant kidney disease
  • Significant liver disease
  • Systemic lupus erythematosus
  • Gastrointestinal disease or surgery that 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): NCT00095550


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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: NCT00095550     History of Changes
Other Study ID Numbers: CV131-185
First Posted: November 8, 2004    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: August 2008

Keywords provided by Bristol-Myers Squibb:
Moderate Hypertension

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Irbesartan
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