Clinical trial NCT00355589: Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension
Official title: A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Efficacy and Safety of a Combination of Ramipril Plus Hydrochlorothiazide Versus the Component Monotherapies in Subjects With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Blood Pressure, High
Keywords: Hypertension
High Blood Pressure
Diuretic
Angiotensin converting enzyme inhibitor
Ambulatory blood pressure monitoring
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-07-24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if there is greater blood pressure reduction using ramipril or hydrochlorothiazide alone or ramipril and hydrochlorothiazide together.


Eligibility criteria: Inclusion Criteria:

* Previously diagnosed, or newly diagnosed essential hypertension. Blood pressure must be within a minimum and maximum range prior to drug treatment.

Exclusion Criteria:

* Inability to discontinue all prior antihypertensive medications
* Heart failure
* History of stroke, myocardial infarction, or chest pain within 3 years, or an abnormal heart rhythm
* Liver or kidney disease
* Certain drugs used to treat other conditions like an enlarged prostate gland, or arthritis
* Allergy or reactions to certain medications used to treat high blood pressure

Other protocol-defined inclusion and exclusion criteria apply.

Primary outcomes:
measure: Compare the effects on sitting diastolic blood pressure of two antihypertensive drugs in combination against each antihypertensive alone after an eight week treatment period.
Secondary outcomes:
measure: Compare the effect on sitting diastolic blood pressure of two antihypertensive drugs in combination taken once daily against one antihypertensive drug taken twice daily.
measure: Compare the effect on sitting diastolic blood pressure of a dose of an antihypertensive drug taken once daily against half of the same dose taken twice daily.
measure: Compare the effect on the sitting and standing blood pressure among all treatment groups.
measure: Compare the safety of each medication regimen stated above.
measure: Compare the effect on mean 24-hour diastolic blood pressure (ABPM) of the medication regimens stated above.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Research Inc.
state: Alabama
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Glendale
country: United States
facility: Pulmonary Associates
state: Arizona
city: Beverly Hills
country: United States
facility: Impact Clinical Trials
state: California
city: Beverly Hills
country: United States
facility: Lovelace Scientific Resources, Inc.
state: California
city: Buena Park
country: United States
facility: Associated Pharmaceutical Research Center, Inc.
state: California
city: Greenbrae
country: United States
facility: Marin Endocrine Care and Research
state: California
city: Long Beach
country: United States
facility: Memorial Research Medical Clinic
state: California
city: Los Angeles
country: United States
facility: The Intermed Group; Samaritan Medical Tower
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Roseville
country: United States
facility: Clinical Trials Research
state: California
city: Studio City
country: United States
facility: Bayview Research Group
state: California
city: Temecula
country: United States
facility: Viking Clinical Research
state: California
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Deland
country: United States
facility: University Clinical Research Deland, Inc.
state: Florida
city: Hollywood
country: United States
facility: South Florida Clinical Research Center
state: Florida
city: Largo
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC
state: Florida
city: Miami
country: United States
facility: Lifespan Research Foundation
state: Florida
city: New Port Richey
country: United States
facility: Sun Coast Clinical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Palm Harbor
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Sarasota
country: United States
facility: Lovelace Scientific Resources
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Atlanta
country: United States
facility: Executive Health and Research Associates, Inc.
state: Georgia
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Chicago
country: United States
facility: James R. Herron, MD, Ltd.
state: Illinois
city: Gurnee
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: Livonia
country: United States
facility: Michigan Institute of Medicine
state: Michigan
city: Traverse City
country: United States
facility: Medical Research Associates
state: Michigan
city: Brooklyn Center
country: United States
facility: Twin Cities Clinical Research
state: Minnesota
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Voorhees
country: United States
facility: Partners in Primary Care
state: New Jersey
city: Fayetteville
country: United States
facility: Cumberland Research Assocites, LLC
state: North Carolina
city: Hickory
country: United States
facility: Unifour Medical Research Associates
state: North Carolina
city: Raleigh
country: United States
facility: Triangle Medical Research Associates
state: North Carolina
city: Statesville
country: United States
facility: The Lipid Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Gynecologic Associates, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group, Inc.
state: Ohio
city: Marion
country: United States
facility: Smith Clinical Research
state: Ohio
city: Mogadore
country: United States
facility: Radiant Research - Mogadore
state: Ohio
city: Norman
country: United States
facility: Lion Research
state: Oklahoma
city: Medford
country: United States
facility: Medford Medical Clinic Research Dept.
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia Health Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Medical Research South
state: South Carolina
city: Columbia
country: United States
facility: SC Clinical Research Center, LLC
state: South Carolina
city: Greer
country: United States
facility: Radiant Research - Greer
state: South Carolina
city: Austin
country: United States
facility: MetaClin Research, Inc.
state: Texas
city: Carrollton
country: United States
facility: Punzi Medical Center
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Radiant Research - San Antonio
state: Texas
city: San Antonio
country: United States
facility: WellMed Medical Management
state: Texas
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
city: Virginia Beach
country: United States
facility: The Chase Wellness Center, Inc
state: Virginia
city: Lakewood
country: United States
facility: Radiant Research - Tacoma
state: Washington
Study officials:
References:
citation: White WB, Cleveland JM, Rolleri RL; Ramipril-Hydrochlorothiazide Study Group. Utility of semiautomatic clinic and 24-h ambulatory blood pressure measurements to evaluate combination therapy: the Ramipril-Hydrochlorothiazide Hypertension trial. J Hum Hypertens. 2008 Aug;22(8):559-68. doi: 10.1038/jhh.2008.26. Epub 2008 May 8.