Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095394
• Other study ID #: CV131-176
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2004
• Last updated: April 7, 2011
• Start date: September 2004
• Est. completion date: May 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 645
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.
• Irbesartan monotherapy
Tablets, Oral, 150 mg, Once daily, 7 weeks.

Locations

Country	Name	City	State
Belgium	Local Institution	Antwerpen
Belgium	Local Institution	Brussels
Belgium	Local Institution	Bruxelles
Belgium	Local Institution	Edegem
Belgium	Local Institution	Genk
Belgium	Local Institution	Hasselt
Belgium	Local Institution	Huy	Luik
Belgium	Local Institution	La Louviere
Belgium	Local Institution	Liege
Belgium	Local Institution	Roeselare
Belgium	Local Institution	Wilrijk
Canada	Local Institution	Aylmer	Ontario
Canada	Local Institution	Bonaventure	Quebec
Canada	Local Institution	Burlington	Ontario
Canada	Local Institution	Chandler	Quebec
Canada	Local Institution	Chicoutimi	Quebec
Canada	Local Institution	Coquitlam	British Columbia
Canada	Local Institution	Drummondville	Quebec
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Greenfield Park	Quebec
Canada	Local Institution	Halifax	Nova Scotia
Canada	Local Institution	Hamilton	Ontario
Canada	Local Institution	London	Ontario
Canada	Local Institution	Markham	Ontario
Canada	Local Institution	Montague	Prince Edward Island
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Niagra Falls	Ontario
Canada	Local Institution	North Vancouver	British Columbia
Canada	Local Institution	Oakville	Ontario
Canada	Local Institution	Oshawa	Ontario
Canada	Local Institution	Quesnel	British Columbia
Canada	Local Institution	Red Deer	Alberta
Canada	Local Institution	Richmond Hill	Ontario
Canada	Local Institution	Saint-Lambert	Quebec
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	Ste-Foy	Quebec
Canada	Local Institution	Thornhill	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Windsor	Ontario
Canada	Local Institution	Winnipeg	Manitoba
France	Local Institution	Ambrieres Les Vallees
France	Local Institution	Angers
France	Local Institution	Bagneux
France	Local Institution	Bouere
France	Local Institution	Chateau Gontier
France	Local Institution	Cherbourg
France	Local Institution	Equeurdreville
France	Local Institution	Evron
France	Local Institution	La Glacerie
France	Local Institution	La Rochelle
France	Local Institution	Laval
France	Local Institution	Le Lion D'Angers
France	Local Institution	Longue
France	Local Institution	Longue Jumelles
France	Local Institution	Louverne
France	Local Institution	Mayenne
France	Local Institution	Nieul Sur Mer
France	Local Institution	Noyant
France	Local Institution	Sainte Suzanne
France	Local Institution	Saumur
France	Local Institution	Villebernier
Germany	Local Institution	Beckum
Germany	Local Institution	Berlin
Germany	Local Institution	Blankenhain
Germany	Local Institution	Essen
Germany	Local Institution	Floersheim
Germany	Local Institution	Frankfurt
Germany	Local Institution	Fuerth
Germany	Local Institution	Georgsmarienhuette
Germany	Local Institution	Germersheim
Germany	Local Institution	Hamburg
Germany	Local Institution	Hannover
Germany	Local Institution	Krombach
Germany	Local Institution	Kuenzing
Germany	Local Institution	Lambrecht
Germany	Local Institution	Loxstedt	Niedersach
Germany	Local Institution	Mainburg
Germany	Local Institution	Mannheim
Germany	Local Institution	Messkirch
Germany	Local Institution	Monheim
Germany	Local Institution	Nuernberg
Germany	Local Institution	Parsberg
Germany	Local Institution	Pforzheim
Germany	Local Institution	Spaichingen	Baden-Wurttembe
Germany	Local Institution	Stuttgart
Germany	Local Institution	Villingen-Schwenningen
Germany	Local Institution	Waldbrunn
Germany	Local Institution	Welver
Israel	Local Institution	Beer-Sheva
Israel	Local Institution	Haifa
Israel	Local Institution	Holon
Israel	Local Institution	Jerusalem
Israel	Local Institution	Kfar Saba
Israel	Local Institution	Matan
Israel	Local Institution	Tel Hashomer
Israel	Local Institution	Zerifin
Netherlands	Local Institution	Beek En Donk
Netherlands	Local Institution	Eindhoven
Netherlands	Local Institution	Hardenberg
Netherlands	Local Institution	Heerlen
Netherlands	Local Institution	Lichtenvoorde
Netherlands	Local Institution	Rijswyk Zh
Netherlands	Local Institution	S. Gravenhage
Netherlands	Local Institution	Tilburg
Netherlands	Local Institution	Venlo
Netherlands	Local Institution	Waalwijk
Netherlands	Local Institution	Woerden
Netherlands	Local Institution	Zeist
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Saratov
Russian Federation	Local Institution	St. Petersburg
United States	Local Institution	Albuquerque	New Mexico
United States	Local Institution	Atlanta	Georgia
United States	Local Institution	Austin	Texas
United States	Local Institution	Ayer	Massachusetts
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	Boulder	Colorado
United States	Local Institution	Bridgeport	Connecticut
United States	Local Institution	Bristol	Tennessee
United States	Local Institution	Bronx	New York
United States	Local Institution	Buffalo	New York
United States	Local Institution	Burke	Virginia
United States	Local Institution	Butte	Montana
United States	Local Institution	Camp Hill	Pennsylvania
United States	Local Institution	Canton	Ohio
United States	Local Institution	Carlsbad	California
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	Charlotte Harbour	Florida
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	Cleveland	Mississippi
United States	Local Institution	cocoa Beach	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	Columbus	Ohio
United States	Local Institution	Cordova	Tennessee
United States	Local Institution	Corona	California
United States	Local Institution	Cranston	Rhode Island
United States	Local Institution	Crestview	Florida
United States	Local Institution	Dallas	Texas
United States	Local Institution	Deland	Florida
United States	Local Institution	Denver	Colorado
United States	Local Institution	Des Moines	Iowa
United States	Local Institution	Dover	New Hampshire
United States	Local Institution	East Syracuse	New York
United States	Local Institution	Elkton	Maryland
United States	Local Institution	Encinitas	California
United States	Local Institution	Erlanger	Kentucky
United States	Local Institution	Eugene	Oregon
United States	Local Institution	Fresno	California
United States	Local Institution	Fulton	New York
United States	Local Institution	Gastonia	North Carolina
United States	Local Institution	Genoa	Ohio
United States	Local Institution	Greensboro	North Carolina
United States	Local Institution	Hampton	Virginia
United States	Local Institution	Hendersonville	Tennessee
United States	Local Institution	High Point	North Carolina
United States	Local Institution	Highlands Ranch	Colorado
United States	Local Institution	Hillsborough	New Jersey
United States	Local Institution	Hollywood	Florida
United States	Local Institution	Huntsville	Alabama
United States	Local Institution	Jacksonville	Florida
United States	Local Institution	Johnson City	Tennessee
United States	Local Institution	Jupiter	Florida
United States	Local Institution	Kansas City	Kansas
United States	Local Institution	Kettering	Ohio
United States	Local Institution	Lacey	Washington
United States	Local Institution	Laguna Hills	California
United States	Local Institution	Lake Jackson	Texas
United States	Local Institution	Lake Success	New York
United States	Local Institution	Landrum	South Carolina
United States	Local Institution	Las Vegas	Nevada
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	Manchester	Missouri
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	Mission Hills	California
United States	Local Institution	Missoula	Montana
United States	Local Institution	Morristown	Tennessee
United States	Local Institution	Mt. Vernon	New York
United States	Local Institution	Nashville	North Carolina
United States	Local Institution	Nashville	Tennessee
United States	Local Institution	New Orleans	Louisiana
United States	Local Institution	New Tazewell	Tennessee
United States	Local Institution	New York	New York
United States	Local Institution	Newark	Delaware
United States	Local Institution	Niceville	Florida
United States	Local Institution	Norfolk	Virginia
United States	Local Institution	North Miami Beach	Florida
United States	Local Institution	Ocala	Florida
United States	Local Institution	Ocoee	Florida
United States	Local Institution	Oklahoma City	Oklahoma
United States	Local Institution	Olean	New York
United States	Local Institution	Olive Branch	Mississippi
United States	Local Institution	Olympia	Washington
United States	Local Institution	Omaha	Nebraska
United States	Local Institution	Orangeburg	Oregon
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	Perrysburg	Ohio
United States	Local Institution	Philadelphia	Pennsylvania
United States	Local Institution	Phoenix	Arizona
United States	Local Institution	Picayune	Mississippi
United States	Local Institution	Port Orange	Florida
United States	Local Institution	Portland	Oregon
United States	Local Institution	Prosperity	South Carolina
United States	Local Institution	Raleigh	California
United States	Local Institution	Redondo Beach	California
United States	Local Institution	Richmond	Kentucky
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	Saluda	South Carolina
United States	Local Institution	San Antonio	Texas
United States	Local Institution	San Diego	California
United States	Local Institution	San Jose	California
United States	Local Institution	Santa Ana	California
United States	Local Institution	Sarasota	Florida
United States	Local Institution	Scottsdale	Arizona
United States	Local Institution	Selmer	Tennessee
United States	Local Institution	Sherwood	Arkansas
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	St. Louis	Missouri
United States	Local Institution	Sudbury	Massachusetts
United States	Local Institution	Summerville	South Carolina
United States	Local Institution	Tamarac	Florida
United States	Local Institution	Tampa	Florida
United States	Local Institution	The Colony	Texas
United States	Local Institution	Torrance	California
United States	Local Institution	Tulsa	Oklahoma
United States	Local Institution	Tustin	California
United States	Local Institution	Vernon Hills	Illinois
United States	Local Institution	Vero Beach	Florida
United States	Local Institution	Waterbury	Connecticut
United States	Local Institution	West Grove	Pennsylvania
United States	Local Institution	Wheat Ridge	Colorado
United States	Local Institution	Wichita	Kansas
United States	Local Institution	Wilmington	North Carolina
United States	Local Institution	Winston Salem	North Carolina
United States	Local Institution	Zephyrhills	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Sanofi

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Israel,  Netherlands,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5
Secondary	Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 17 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