Back to resultsDORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension (Darusentan)
Primary Purpose
Hypertension
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Darusentan
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Resistant Hypertension
Eligibility Criteria
Inclusion Criteria: Subjects who have completed the Treatment Period of clinical trial DAR-311 Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic Exclusion Criteria: Subjects who discontinued treatment with study drug prior to the end of the Treatment Period of DAR-311 due to a study drug-related adverse event (AE) Treatment with another endothelin receptor antagonist within 6 months of study entry
Sites / Locations
- Comprehensive Heart Failure Center
- Canyon Clinical Research
- Chrishard Medical Group
- VA Medical Center - WLA
- Sacramento Heart and Vascular
- Apex Research Institute
- Complete Renal Care
- Connecticut Clinical Research, LLC
- MedStar Diabetes Institute at Washington Hospital Center
- White-Wilson Medical Center
- A.G.A. Clinical Trials
- Jacksonville Center for Clinical
- Ricardo A. Bedoya, Cardiology
- International Research Association
- Cardiovascular Center of Sarasota
- Tampa Bay Nephrology Associates, PL
- Metabolic Research Institute, Inc.
- Global Research Partners
- Kula Research
- Chicago Heart & Vein Clinic
- Evanston Northwestern Healthcare
- Clinical Investigation Specialists, Inc.
- Midwest Heart Foundation
- Medical Research Institute
- Androscoggin Cardiology Associates
- Maine Research Associate
- Cardiovascular Consultants of Maine
- Clinical Associates
- Rockville Internal Medicine Group
- Professional Clinical Research
- Hurley Medical Center
- Professional Clinical Research
- Specialty Medical Center
- Physicians East, PA
- The Lindner Clinical Trial Center
- COR Clinical Research
- Southwest Cardiology Associates
- Castlerock Clinical Research Consultants
- Hillsboro Cardiology, PC
- Northeast Clinical Research Centers, Inc.
- Heritage Cardiology Associates
- Brandywine Clinical Research
- Green and Seidner Family Practice Associates
- Temple University Hospital
- RI Hospital
- Neem Research Group, Inc.
- Internal Medicine & Industrial Medicine
- T&R Clinical, P.A.
- Pri-Med Care
- Innovative Clinical Trials
- Burke Internal Medicine, Inc.
- Manassas Clinical Research Center
- Liberty Research Center
- CIMEL
- DIM (Clinica Privada)
- Fundapres
- Hospital Britanico de Buenos Aires
- Hospital Jose Maria Ramos Meijia
- Hospital Municipal Bernardo Houssay
- Medeos
- Sanatorio Municipal
- Centro Integrado Hospital do Rim e Hipertensao
- Centro Integrado Hospital
- Cambridge Cardiac Care Center
- Clinical Research Solutions
- Hvidovre Hospital
- Bispebjerg Hospital
- CIC Hopital Jeanne D'Arc
- CHU de Grenoble
- Hôpital Civil, Service HTA maladies vasculaires
- Cardiovascular Research, Karolinska Institue
- University Hospital Umea
- Townhead Surgery
- Avenue Surgery
- Hathaway Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Darusentan 50 mg
Darusentan 100 mg
Darusentan 300 mg
Arm Description
Darusentan 50 mg administered orally once daily
Darusentan 100 mg administered orally once daily
Darusentan 300 mg administered orally once daily
Outcomes
Primary Outcome Measures
Change in trough sitting systolic and diastolic blood pressure
Secondary Outcome Measures
Change in mean 24-hour systolic and diastolic ambulatory blood pressures.
Percentage of subjects who reach systolic blood pressure goal
Change in estimated glomerular filtration rate (eGFR)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00353574
Brief Title
DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension
Acronym
Darusentan
Official Title
DORADO-EX - A Dose-Blinded, Long-Term Safety Extension Study of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311-E)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
Study DAR-312 did not meet primary co-endpoints
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, including a diuretic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Resistant Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
282 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Darusentan 50 mg
Arm Type
Experimental
Arm Description
Darusentan 50 mg administered orally once daily
Arm Title
Darusentan 100 mg
Arm Type
Experimental
Arm Description
Darusentan 100 mg administered orally once daily
Arm Title
Darusentan 300 mg
Arm Type
Experimental
Arm Description
Darusentan 300 mg administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Darusentan
Intervention Description
Darusentan capsules administered orally once daily
Primary Outcome Measure Information:
Title
Change in trough sitting systolic and diastolic blood pressure
Time Frame
Baseline to Week 14
Secondary Outcome Measure Information:
Title
Change in mean 24-hour systolic and diastolic ambulatory blood pressures.
Time Frame
Baseline to Week 14
Title
Percentage of subjects who reach systolic blood pressure goal
Time Frame
Week 14
Title
Change in estimated glomerular filtration rate (eGFR)
Time Frame
Baseline to Week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who have completed the Treatment Period of clinical trial DAR-311
Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
Exclusion Criteria:
Subjects who discontinued treatment with study drug prior to the end of the Treatment Period of DAR-311 due to a study drug-related adverse event (AE)
Treatment with another endothelin receptor antagonist within 6 months of study entry
Facility Information:
Facility Name
Comprehensive Heart Failure Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Canyon Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Chrishard Medical Group
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
VA Medical Center - WLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Sacramento Heart and Vascular
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Apex Research Institute
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Complete Renal Care
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Connecticut Clinical Research, LLC
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
MedStar Diabetes Institute at Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
White-Wilson Medical Center
City
Fort Walton Beach
State/Province
Florida
ZIP/Postal Code
32569
Country
United States
Facility Name
A.G.A. Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Jacksonville Center for Clinical
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Ricardo A. Bedoya, Cardiology
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
International Research Association
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Cardiovascular Center of Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34231
Country
United States
Facility Name
Tampa Bay Nephrology Associates, PL
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Metabolic Research Institute, Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Global Research Partners
City
Calhoun
State/Province
Georgia
ZIP/Postal Code
30701
Country
United States
Facility Name
Kula Research
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Chicago Heart & Vein Clinic
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Clinical Investigation Specialists, Inc.
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Midwest Heart Foundation
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Medical Research Institute
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Androscoggin Cardiology Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Maine Research Associate
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Cardiovascular Consultants of Maine
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Clinical Associates
City
Reisterstown
State/Province
Maryland
ZIP/Postal Code
21136
Country
United States
Facility Name
Rockville Internal Medicine Group
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
Professional Clinical Research
City
Benzonia
State/Province
Michigan
ZIP/Postal Code
49616
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Professional Clinical Research
City
Interlochen
State/Province
Michigan
ZIP/Postal Code
49643
Country
United States
Facility Name
Specialty Medical Center
City
Pahrump
State/Province
Nevada
ZIP/Postal Code
89048
Country
United States
Facility Name
Physicians East, PA
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
The Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
COR Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73003
Country
United States
Facility Name
Southwest Cardiology Associates
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Castlerock Clinical Research Consultants
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Hillsboro Cardiology, PC
City
Hillsboro
State/Province
Oregon
ZIP/Postal Code
97123
Country
United States
Facility Name
Northeast Clinical Research Centers, Inc.
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Heritage Cardiology Associates
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Brandywine Clinical Research
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
Facility Name
Green and Seidner Family Practice Associates
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
RI Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Neem Research Group, Inc.
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Internal Medicine & Industrial Medicine
City
Desoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
T&R Clinical, P.A.
City
Ft Worth
State/Province
Texas
ZIP/Postal Code
76117
Country
United States
Facility Name
Pri-Med Care
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75067
Country
United States
Facility Name
Innovative Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Burke Internal Medicine, Inc.
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
Liberty Research Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
CIMEL
City
Buenos Aires
Country
Argentina
Facility Name
DIM (Clinica Privada)
City
Buenos Aires
Country
Argentina
Facility Name
Fundapres
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Jose Maria Ramos Meijia
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Municipal Bernardo Houssay
City
Buenos Aires
Country
Argentina
Facility Name
Medeos
City
Buenos Aires
Country
Argentina
Facility Name
Sanatorio Municipal
City
Buenos Aires
Country
Argentina
Facility Name
Centro Integrado Hospital do Rim e Hipertensao
City
Sao Paulo
Country
Brazil
Facility Name
Centro Integrado Hospital
City
Sao Paulo
Country
Brazil
Facility Name
Cambridge Cardiac Care Center
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N3H 3R8
Country
Canada
Facility Name
Clinical Research Solutions
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G5
Country
Canada
Facility Name
Hvidovre Hospital
City
Hvidovre
Country
Denmark
Facility Name
Bispebjerg Hospital
City
København
Country
Denmark
Facility Name
CIC Hopital Jeanne D'Arc
City
Dommartin les Toul
Country
France
Facility Name
CHU de Grenoble
City
Grenoble Cedex
Country
France
Facility Name
Hôpital Civil, Service HTA maladies vasculaires
City
Strasbourg Cedex
Country
France
Facility Name
Cardiovascular Research, Karolinska Institue
City
Stockholm
Country
Sweden
Facility Name
University Hospital Umea
City
Umea
Country
Sweden
Facility Name
Townhead Surgery
City
Scotland
Country
United Kingdom
Facility Name
Avenue Surgery
City
Wiltshire
Country
United Kingdom
Facility Name
Hathaway Medical Centre
City
Wiltshire
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.gilead.com
Description
Related Info
Learn more about this trial
DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension
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