Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension

Hypertension Clinical Trial

Official title:

The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Patients With Moderate Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095550
• Other study ID #: CV131-185
• Status: Completed
• Phase: Phase 3
• First received: November 5, 2004
• Last updated: April 7, 2011
• Start date: October 2004
• Est. completion date: June 2005

Study information

• Verified date: August 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 496
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Irbesartan/HCTZ
Tablets, Oral, Irbesartan 150 mg/HCTZ 12.5 mg, Once daily, 12 weeks.
• Irbesartan monotherapy
Tablets, Oral, 150 mg, Once daily, 12 weeks.
• HCTZ monotherapy
Tablets, Oral, 12.5 mg, Once daily, 12 weeks.

Locations

Country	Name	City	State
Canada	Local Institution	Aylmer	Ontario
Canada	Local Institution	Burlington	Ontario
Canada	Local Institution	Coquitlam	British Columbia
Canada	Local Institution	Drummondville	Quebec
Canada	Local Institution	Greenfield Park	Quebec
Canada	Local Institution	Halifax	Nova Scotia
Canada	Local Institution	Hamilton	Ontario
Canada	Local Institution	Markham	Ontario
Canada	Local Institution	Montague	Prince Edward Island
Canada	Local Institution	North Vancouver	British Columbia
Canada	Local Institution	Oakville	Ontario
Canada	Local Institution	Oshawa	Ontario
Canada	Local Institution	Red Deer	Alberta
Canada	Local Institution	Richmond Hill	Ontario
Canada	Local Institution	Sarnia	Ontario
Canada	Local Institution	Saskatoon	Saskatchewan
Canada	Local Institution	Sidney	British Columbia
Canada	Local Institution	St. Johns	Newfoundland and Labrador
Canada	Local Institution	St. Lambert	Quebec
Canada	Local Institution	Thornhill	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Winnipeg	Manitoba
France	Local Institution	Angers
France	Local Institution	Bouchemaine
France	Local Institution	Briollay
France	Local Institution	Tierce
Germany	Local Institution	Berlin
Germany	Local Institution	Essen
Germany	Local Institution	Feldafing
Germany	Local Institution	Groemitz
Germany	Local Institution	Kuenzing
Germany	Local Institution	Noerten-hardenberg
Germany	Local Institution	Nuernberg
Germany	Local Institution	Ornbau
Germany	Local Institution	Spaichingen	Baden-Wurttembe
Germany	Local Institution	Spaichingen	Braden-Wurttembe
Germany	Local Institution	Unterschneidheim
Germany	Local Institution	Villingen-schwenningen
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Saratov
Russian Federation	Local Institution	St. Petersburg
United States	Local Institution	Atlanta	Georgia
United States	Local Institution	Austin	Texas
United States	Local Institution	Baltimore	Maryland
United States	Local Institution	Bartlett	Tennessee
United States	Local Institution	Bensalem	Pennsylvania
United States	Local Institution	Birmingham	Alabama
United States	Local Institution	Bridgeport	Connecticut
United States	Local Institution	Bronx	New York
United States	Local Institution	Buffalo	New York
United States	Local Institution	Camp Hill	Pennsylvania
United States	Local Institution	Canton	Ohio
United States	Local Institution	Carmichael	California
United States	Local Institution	Chalmette	Louisiana
United States	Local Institution	Charleston	South Carolina
United States	Local Institution	Charlotte	North Carolina
United States	Local Institution	Charlottesville	Virginia
United States	Local Institution	Chicago	Illinois
United States	Local Institution	Chipley	Florida
United States	Local Institution	Cincinnati	Ohio
United States	Local Institution	Clearwater	Florida
United States	Local Institution	Collegeville	Pennsylvania
United States	Local Institution	Colleyville	Texas
United States	Local Institution	Columbia	South Carolina
United States	Local Institution	Columbiana	Alabama
United States	Local Institution	Crestview	Florida
United States	Local Institution	Deland	Florida
United States	Local Institution	Dover	New Hampshire
United States	Local Institution	Eugene	Oregon
United States	Local Institution	Fair Oaks	California
United States	Local Institution	Fresno	California
United States	Local Institution	Gastonia	North Carolina
United States	Local Institution	Genoa	Ohio
United States	Local Institution	Greensboro	North Carolina
United States	Local Institution	Hendersonville	Tennessee
United States	Local Institution	Highlands Ranch	Colorado
United States	Local Institution	Hollywood	Florida
United States	Local Institution	Jacksonville	Florida
United States	Local Institution	Kettering	Ohio
United States	Local Institution	Levittown	Pennsylvania
United States	Local Institution	Livonia	Michigan
United States	Local Institution	Long Beach	California
United States	Local Institution	Lyndhurst	Ohio
United States	Local Institution	Madison	Wisconsin
United States	Local Institution	Medford	Oregon
United States	Local Institution	Mesa	Arizona
United States	Local Institution	Miami	Florida
United States	Local Institution	Midland	Texas
United States	Local Institution	Milwaukee	Wisconsin
United States	Local Institution	Mint Hill	North Carolina
United States	Local Institution	Missoula	Montana
United States	Local Institution	Mt. Vernon	New York
United States	Local Institution	Nashville	Tennessee
United States	Local Institution	New Orleans	Louisiana
United States	Local Institution	New York	New York
United States	Local Institution	Newark	Delaware
United States	Local Institution	Niceville	Florida
United States	Local Institution	Ocoee	Florida
United States	Local Institution	Oklahoma City	Oklahoma
United States	Local Institution	Olive Branch	Mississippi
United States	Local Institution	Olympia	Washington
United States	Local Institution	Orangeburg	South Carolina
United States	Local Institution	Oxon Hill	Maryland
United States	Local Institution	Pembroke Pines	Florida
United States	Local Institution	Penndel	Pennsylvania
United States	Local Institution	Peoria	Illinois
United States	Local Institution	Philadelphia	Pennsylvania
United States	Local Institution	Phoenix	Arizona
United States	Local Institution	Portland	Oregon
United States	Local Institution	Rolling Hills Estate	California
United States	Local Institution	Roseville	California
United States	Local Institution	Sacramento	California
United States	Local Institution	Saginaw	Michigan
United States	Local Institution	Salt Lake City	Utah
United States	Local Institution	San Antonio	Texas
United States	Local Institution	San Jose	California
United States	Local Institution	Selmer	Tennessee
United States	Local Institution	Simpsonville	South Carolina
United States	Local Institution	South Bound Brook	New Jersey
United States	Local Institution	Spokane	Washington
United States	Local Institution	Springfield	Massachusetts
United States	Local Institution	St. Cloud	Florida
United States	Local Institution	Summerville	South Carolina
United States	Local Institution	Torrance	California
United States	Local Institution	Tustin	California
United States	Local Institution	Waterbury	Connecticut
United States	Local Institution	West Grove	Pennsylvania
United States	Local Institution	Winston Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Sanofi

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in SeSBP at Week 8
Secondary	Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 12 weeks of therapy.

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm