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

November 3, 2004
April 7, 2011
September 2004
May 2005   (final data collection date for primary outcome measure)
Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5
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Complete list of historical versions of study NCT00095394 on ClinicalTrials.gov Archive Site
Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 17 weeks of therapy.
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Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension
The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Severe Hypertension

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • 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
  • Experimental: A1
    Intervention: Drug: Irbesartan/HCTZ
  • Active Comparator: A2
    Intervention: Drug: Irbesartan monotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
645
May 2005
May 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   France,   Germany,   Israel,   Netherlands,   Russian Federation
 
NCT00095394
CV131-176
Not Provided
Not Provided
Bristol-Myers Squibb
Sanofi
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2008

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