Clinical trial NCT00095394: Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension
Official title: The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Severe Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Severe Hypertension
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2004-11-04
Enrollment: 645
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5
Secondary outcomes:
measure: Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 17 weeks of therapy.
Other outcomes:
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state: Saskatchewan
city: Ambrieres Les Vallees
country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: Germany
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state: Baden-Wurttembe
city: Loxstedt
country: Germany
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state: Niedersach
city: Beckum
country: Germany
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city: Berlin
country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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city: Georgsmarienhuette
country: Germany
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country: Germany
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city: Hamburg
country: Germany
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city: Hannover
country: Germany
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city: Krombach
country: Germany
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city: Kuenzing
country: Germany
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city: Lambrecht
country: Germany
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city: Mainburg
country: Germany
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city: Mannheim
country: Germany
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city: Messkirch
country: Germany
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city: Monheim
country: Germany
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city: Nuernberg
country: Germany
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city: Parsberg
country: Germany
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city: Pforzheim
country: Germany
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city: Stuttgart
country: Germany
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city: Villingen-Schwenningen
country: Germany
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city: Waldbrunn
country: Germany
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city: Welver
country: Germany
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city: Beer-Sheva
country: Israel
facility: Local Institution
city: Haifa
country: Israel
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city: Holon
country: Israel
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city: Jerusalem
country: Israel
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city: Kfar Saba
country: Israel
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city: Matan
country: Israel
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city: Tel Hashomer
country: Israel
facility: Local Institution
city: Zerifin
country: Israel
facility: Local Institution
city: Beek En Donk
country: Netherlands
facility: Local Institution
city: Eindhoven
country: Netherlands
facility: Local Institution
city: Hardenberg
country: Netherlands
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city: Heerlen
country: Netherlands
facility: Local Institution
city: Lichtenvoorde
country: Netherlands
facility: Local Institution
city: Rijswyk Zh
country: Netherlands
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city: S. Gravenhage
country: Netherlands
facility: Local Institution
city: Tilburg
country: Netherlands
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city: Venlo
country: Netherlands
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city: Waalwijk
country: Netherlands
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city: Woerden
country: Netherlands
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city: Zeist
country: Netherlands
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
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: