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DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension (Darusentan)

Primary Purpose

Hypertension

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Darusentan
Guanfacine
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

SELECTED INCLUSION CRITERIA:

  1. Subjects must be competent to provide written informed consent;
  2. Subjects must have completed the Maintenance Period of the DAR-312 study.

SELECTED EXCLUSION CRITERIA:

  1. Subjects who discontinue treatment with study drug prior to the end of the Maintenance Period in DAR-312 due to a study drug-related AE;
  2. Subjects who experience a study drug-related serious adverse event (SAE) during the DAR-312 study.

Sites / Locations

  • Alabama Internal Medicine, PC
  • Greystone Medical Research, LLC
  • The Heart Center, PC
  • Mulberry Medical Associates, PC
  • Arizona Center for Clinical Research
  • Cardiovascular Consultants, Ltd.
  • Lovelace Scientific Resource, Inc.
  • Cochise Clinical Research
  • Southwest Heart
  • HealthFirst Physicians of AR, PA dba Convenient Care Clinic
  • NEA Clinical
  • Arkansas Primary Care Clinic, PA
  • Medical Investigators, Inc.
  • Highgrove Medical Center
  • Central Cardiology Medical Clinic
  • Impact Clinical Trials
  • VA Greater Los Angeles Healthcare System
  • Rancho Cucamonga Clinical Trials
  • Pacific Heart Institute
  • Los angeles biomedical research Institute at Harbor-UCLA Medical Center
  • Aurora Denver Cardiology Associates
  • Aurora Denver Cardiology Associates
  • Clinical Research of South Florida
  • Doctors Medical center of Walton County
  • Broward General Medical Center
  • Maxine Hamilton, MD, PA
  • St John's Center for Clinical Research
  • Private Practice of Dr. Bridget Bellingar
  • A + Research Inc.
  • AppleMed Research, Inc.
  • Internal Medicine Associates of South Florida
  • Ormond Medical Arts Pharmaceutical Research Center
  • Nothwest Florida Heart Group, PA-Research Dept
  • Cardiovascular Center of Sarasota
  • Suncoast Cardiovascular Research, Inc
  • Tampa Bay Nephrology Associates, PL
  • Orlando Rangel, MD, PA
  • AMR Research Associates, LLC
  • Atlanta Vascular Research Foundation
  • Consultants in Cardiovascular Med (CIS)
  • Illinois Heart & Lunch Research Center
  • Methodist Medical Center-Heart, Lung & Vascular Institute
  • Medical consultants, PC
  • University Medical Associates
  • Dr. Jeffrey Chen
  • Louisiana Research Associates, Inc.
  • Maine Research Associates
  • PrimeCare Internal Medicine
  • Great Lakes Heart Center of Alpena
  • Internal Medicine of Northern Michigan
  • Minneapolis VAMC
  • Central Minnesota Heart Center at St. Cloud Hospital
  • St. Paul Cardiology
  • Glacier View Cardiology, PC
  • Impact Clinical Trials
  • NJ Heart
  • New Jersey Physicians
  • Lifeline Research Institute
  • Metrolina Internal Medicine, PA
  • Heart Care Center of Charlotte
  • Physicians East, PA
  • Plaza Medical Group, PC
  • Castlerock Clinical Research Consultants, LLC
  • Integrated Medical Research PC
  • Blackstone Cardiology Associates
  • Charleston Cardiology
  • Paris View Family Practice
  • Internal Medicine of Greer
  • Scenic City Research
  • Southeast Texas Clinical Research Center
  • Cardiovascular Research Inst. of Dallas
  • Galenos Research
  • Sergio F Rovner, MD
  • Salim Gopalani, MD, PA
  • Humayum Mirza, MD, PA
  • Clinical Trial Network
  • Houston Clinical Research Assoc.
  • Innovative Research of West Florida
  • North Texas Medical Research
  • Scott & White Memorial Hospital
  • Fletcher Allen Health Care/University of Vermont
  • Kamlesh N Dave Cardiology
  • WVU Physicicans of Charleston
  • Alpha Medical Research, LLC
  • Executive Health and Research Associates
  • Instituto de Investigaciones Clinicas Bahia Blanca
  • Consultorios Medicos Privados S.A.
  • Policlinica Bancaria "9 de Julio"
  • Diabaid (Instituto de Asistencia Integral en Diabetes)
  • MD Investigaciones
  • Instituto de Cardiologia de Corrientes
  • Framingham Centro Medico
  • Instituto de Investigaciones Clinicas Mar del Plata
  • Instituto de Investigaciones Clinicas de Quilmes
  • Instituto de Investigaciones Clinicas
  • Centro de Investigaciones clincas de Litoral
  • Flinders Medical Centre
  • Royal Perth Hospital
  • Private Practice of Dr. Herwig Van Aerde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Darusentan

Guanfacine

Arm Description

Darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily

Guanfacine 1 mg capsules administered orally once daily

Outcomes

Primary Outcome Measures

Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure
Percentage of subjects who reach systolic blood pressure goal
Change from baseline in estimated glomerular filtration rate (eGFR)

Secondary Outcome Measures

Change from baseline in trough sitting systolic and diastolic blood pressures

Full Information

First Posted
October 17, 2006
Last Updated
January 3, 2014
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00389675
Brief Title
DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension
Acronym
Darusentan
Official Title
A Double-Blind, Active-Controlled, Long-Term Safety Extension Study of Optimized Doses of Darusentan in Subjects With Resistant Hypertension Despite Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine (Protocol DAR-312-E)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
Study DAR-312 did not meet its primary co-endpoints.
Study Start Date
May 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
May 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 double-blind, active-controlled, long-term study of a new experimental drug called darusentan. Darusentan in not currently approved by the United States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan (optimized dose) as compared to an active control, administered orally.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
661 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Darusentan
Arm Type
Experimental
Arm Description
Darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily
Arm Title
Guanfacine
Arm Type
Active Comparator
Arm Description
Guanfacine 1 mg capsules administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Darusentan
Other Intervention Name(s)
LU 135252
Intervention Description
Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Guanfacine
Intervention Description
Guanfacine 1 mg capsules administered orally once daily
Primary Outcome Measure Information:
Title
Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure
Time Frame
Baseline to Week 14
Title
Percentage of subjects who reach systolic blood pressure goal
Time Frame
Week 14
Title
Change from baseline in estimated glomerular filtration rate (eGFR)
Time Frame
Baseline to Week 14
Secondary Outcome Measure Information:
Title
Change from baseline in trough sitting systolic and diastolic blood pressures
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
SELECTED INCLUSION CRITERIA: Subjects must be competent to provide written informed consent; Subjects must have completed the Maintenance Period of the DAR-312 study. SELECTED EXCLUSION CRITERIA: Subjects who discontinue treatment with study drug prior to the end of the Maintenance Period in DAR-312 due to a study drug-related AE; Subjects who experience a study drug-related serious adverse event (SAE) during the DAR-312 study.
Facility Information:
Facility Name
Alabama Internal Medicine, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Greystone Medical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
The Heart Center, PC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Mulberry Medical Associates, PC
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Arizona Center for Clinical Research
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Cardiovascular Consultants, Ltd.
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Lovelace Scientific Resource, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Cochise Clinical Research
City
Sierra Vista
State/Province
Arizona
ZIP/Postal Code
85635
Country
United States
Facility Name
Southwest Heart
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
HealthFirst Physicians of AR, PA dba Convenient Care Clinic
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
NEA Clinical
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Arkansas Primary Care Clinic, PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Medical Investigators, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Highgrove Medical Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Central Cardiology Medical Clinic
City
Bakersfield
State/Province
California
ZIP/Postal Code
93308
Country
United States
Facility Name
Impact Clinical Trials
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Rancho Cucamonga Clinical Trials
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Pacific Heart Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Los angeles biomedical research Institute at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Aurora Denver Cardiology Associates
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Aurora Denver Cardiology Associates
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Doctors Medical center of Walton County
City
Defuniak Springs
State/Province
Florida
ZIP/Postal Code
32435
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Maxine Hamilton, MD, PA
City
Ft Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
St John's Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32259
Country
United States
Facility Name
Private Practice of Dr. Bridget Bellingar
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
A + Research Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
AppleMed Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Internal Medicine Associates of South Florida
City
N. Miami Beach
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Facility Name
Ormond Medical Arts Pharmaceutical Research Center
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Nothwest Florida Heart Group, PA-Research Dept
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Cardiovascular Center of Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34231
Country
United States
Facility Name
Suncoast Cardiovascular Research, Inc
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Tampa Bay Nephrology Associates, PL
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Orlando Rangel, MD, PA
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
AMR Research Associates, LLC
City
Bogart
State/Province
Georgia
ZIP/Postal Code
30622
Country
United States
Facility Name
Atlanta Vascular Research Foundation
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
Consultants in Cardiovascular Med (CIS)
City
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
Country
United States
Facility Name
Illinois Heart & Lunch Research Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Methodist Medical Center-Heart, Lung & Vascular Institute
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61606
Country
United States
Facility Name
Medical consultants, PC
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
University Medical Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Dr. Jeffrey Chen
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Louisiana Research Associates, Inc.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Maine Research Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
PrimeCare Internal Medicine
City
Biddeford
State/Province
Maine
ZIP/Postal Code
04005
Country
United States
Facility Name
Great Lakes Heart Center of Alpena
City
Alpena
State/Province
Michigan
ZIP/Postal Code
49707
Country
United States
Facility Name
Internal Medicine of Northern Michigan
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Minneapolis VAMC
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Central Minnesota Heart Center at St. Cloud Hospital
City
St. Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
St. Paul Cardiology
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Glacier View Cardiology, PC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Impact Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
NJ Heart
City
Linden
State/Province
New Jersey
ZIP/Postal Code
07036
Country
United States
Facility Name
New Jersey Physicians
City
Passaic
State/Province
New Jersey
ZIP/Postal Code
07055
Country
United States
Facility Name
Lifeline Research Institute
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
Facility Name
Metrolina Internal Medicine, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Heart Care Center of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Physicians East, PA
City
Winterville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Plaza Medical Group, PC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Castlerock Clinical Research Consultants, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Integrated Medical Research PC
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
Blackstone Cardiology Associates
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Charleston Cardiology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Paris View Family Practice
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Internal Medicine of Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Scenic City Research
City
Cleveland
State/Province
Tennessee
ZIP/Postal Code
37311
Country
United States
Facility Name
Southeast Texas Clinical Research Center
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Cardiovascular Research Inst. of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Galenos Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Sergio F Rovner, MD
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Facility Name
Salim Gopalani, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Humayum Mirza, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Houston Clinical Research Assoc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Innovative Research of West Florida
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
North Texas Medical Research
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Scott & White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Fletcher Allen Health Care/University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Kamlesh N Dave Cardiology
City
Hopewell
State/Province
Virginia
ZIP/Postal Code
23860
Country
United States
Facility Name
WVU Physicicans of Charleston
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Alpha Medical Research, LLC
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
43717
Country
United States
Facility Name
Executive Health and Research Associates
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
Facility Name
Instituto de Investigaciones Clinicas Bahia Blanca
City
Bahia Blanca
Country
Argentina
Facility Name
Consultorios Medicos Privados S.A.
City
Buenos Aires
Country
Argentina
Facility Name
Policlinica Bancaria "9 de Julio"
City
Buenos Aires
Country
Argentina
Facility Name
Diabaid (Instituto de Asistencia Integral en Diabetes)
City
Ciudad de Buenos Aires
Country
Argentina
Facility Name
MD Investigaciones
City
Ciudad de Buenos Aires
Country
Argentina
Facility Name
Instituto de Cardiologia de Corrientes
City
Corrientes
Country
Argentina
Facility Name
Framingham Centro Medico
City
La Plata
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas Mar del Plata
City
Mar del Plata
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas de Quilmes
City
Quilmes
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas
City
Rosario
Country
Argentina
Facility Name
Centro de Investigaciones clincas de Litoral
City
Santa Fe
Country
Argentina
Facility Name
Flinders Medical Centre
City
Bedford
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
Country
Australia
Facility Name
Private Practice of Dr. Herwig Van Aerde
City
Rio de Janeiro
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.gilead.com
Description
Related Info

Learn more about this trial

DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension

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