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

Tracking Information
First Submitted Date  ICMJE November 3, 2004
First Posted Date  ICMJE November 4, 2004
Last Update Posted Date April 15, 2011
Study Start Date  ICMJE September 2004
Actual Primary Completion Date May 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 17 weeks of therapy.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension
Official Title  ICMJE The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Severe Hypertension
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Irbesartan/HCTZ
    Tablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.
    Other Name: Avapro
  • Drug: Irbesartan monotherapy
    Tablets, Oral, 150 mg, Once daily, 7 weeks.
    Other Name: Avapro
Study Arms  ICMJE
  • Experimental: A1
    Intervention: Drug: Irbesartan/HCTZ
  • Active Comparator: A2
    Intervention: Drug: Irbesartan monotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 9, 2005)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2005
Actual Primary Completion Date May 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Germany,   Israel,   Netherlands,   Russian Federation,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00095394
Other Study ID Numbers  ICMJE CV131-176
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP