Status:
COMPLETED
Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Sanofi
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2005
Estimated Enrollment :
645 Patients enrolled
Trial Details
Trial ID
NCT00095394
Start Date
September 1 2004
End Date
May 1 2005
Last Update
April 15 2011
Active Locations (269)
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1
Local Institution
Birmingham, Alabama, United States
2
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Columbiana, Alabama, United States
3
Local Institution
Huntsville, Alabama, United States
4
Local Institution
Mesa, Arizona, United States