Status:
COMPLETED
Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate 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 moderate hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2005
Estimated Enrollment :
496 Patients enrolled
Trial Details
Trial ID
NCT00095550
Start Date
October 1 2004
End Date
June 1 2005
Last Update
April 15 2011
Active Locations (128)
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Birmingham, Alabama, United States
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Columbiana, Alabama, United States
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Mesa, Arizona, United States
4
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Phoenix, Arizona, United States