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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00095394
First received: November 3, 2004
Last updated: April 7, 2011
Last verified: August 2008
History of Changes
  Purpose

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 Intervention Phase
Hypertension
 Drug: Irbesartan/HCTZ
Drug: Irbesartan monotherapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Severe Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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

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

Estimated Enrollment: 645
Study Start Date: September 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095394

  Show 270 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Sanofi
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00095394     History of Changes
Other Study ID Numbers: CV131-176
Study First Received: November 3, 2004
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Severe Hypertension

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

ClinicalTrials.gov processed this record on May 19, 2013