Clinical trial NCT00095550: Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension
Official title: The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Patients With Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Moderate Hypertension
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2004-11-08
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.


Eligibility criteria: Inclusion Criteria:

* 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 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 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

Primary outcomes:
measure: Change from baseline in SeSBP at Week 8
Secondary outcomes:
measure: Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 12 weeks of therapy.
Other outcomes:
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facility: Local Institution
state: Alabama
city: Columbiana
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state: Alabama
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city: Drummondville
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city: Greenfield Park
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city: St. Lambert
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city: Saskatoon
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state: Saskatchewan
city: Angers
country: France
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country: France
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city: Briollay
country: France
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city: Tierce
country: France
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city: Spaichingen
country: Germany
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state: Baden-Wurttembe
city: Spaichingen
country: Germany
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state: Braden-Wurttembe
city: Berlin
country: Germany
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city: Essen
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city: Moscow
country: Russian Federation
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city: Saratov
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: