HypertensionPhase 3DarusentanNCT00353574
DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension
A Phase 3 study testing Darusentan in people with Hypertension, run by Gilead Sciences at 75 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Darusentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 75 sitesin 8 countries
- Study dates
- Sep 2006to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
75 sites in 8 countries.
75 sites in 8 countries
United States53 sites
Northeast Clinical Research Centers, Inc.
Allentown, Pennsylvania, 18103
Androscoggin Cardiology Associates
Auburn, Maine, 04210
Maine Research Associate
Auburn, Maine, 04210
Professional Clinical Research
Benzonia, Michigan, 49616
Connecticut Clinical Research, LLC
Bridgeport, Connecticut, 06606
Burke Internal Medicine, Inc.
Burke, Virginia, 22015
Global Research Partners
Calhoun, Georgia, 30701
Heritage Cardiology Associates
Camp Hill, Pennsylvania, 17011
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
Neem Research Group, Inc.
Columbia, South Carolina, 29201
Complete Renal Care
Denver, Colorado, 80220
Internal Medicine & Industrial Medicine
DeSoto, Texas, 75115
Brandywine Clinical Research
Downingtown, Pennsylvania, 19335
Chicago Heart & Vein Clinic
Elk Grove Village, Illinois, 60007
Evanston Northwestern Healthcare
Evanston, Illinois, 60201
Hurley Medical Center
Flint, Michigan, 48503
White-Wilson Medical Center
Fort Walton Beach, Florida, 32569
T&R Clinical, P.A.
Fort Worth, Texas, 76117
Physicians East, PA
Greenville, North Carolina, 27834
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031
A.G.A. Clinical Trials
Hialeah, Florida, 33012
Hillsboro Cardiology, PC
Hillsboro, Oregon, 97123
Kula Research
Honolulu, Hawaii, 96816
Chrishard Medical Group
Inglewood, California, 90301
Professional Clinical Research
Interlochen, Michigan, 49643
Jacksonville Center for Clinical
Jacksonville, Florida, 32216
Ricardo A. Bedoya, Cardiology
Jupiter, Florida, 33458
Green and Seidner Family Practice Associates
Lansdale, Pennsylvania, 19446
Pri-Med Care
Lewisville, Texas, 75067
Midwest Heart Foundation
Lombard, Illinois, 60148
VA Medical Center - WLA
Los Angeles, California, 90073
Manassas Clinical Research Center
Manassas, Virginia, 20110
International Research Association
Miami, Florida, 33156
Comprehensive Heart Failure Center
Mobile, Alabama, 36608
COR Clinical Research
Oklahoma City, Oklahoma, 73003
Southwest Cardiology Associates
Oklahoma City, Oklahoma, 73109
Specialty Medical Center
Pahrump, Nevada, 89048
Temple University Hospital
Philadelphia, Pennsylvania, 19140
RI Hospital
Providence, Rhode Island, 02903
Clinical Associates
Reisterstown, Maryland, 21136
Rockville Internal Medicine Group
Rockville, Maryland, 20854
Sacramento Heart and Vascular
Sacramento, California, 95825
Innovative Clinical Trials
San Antonio, Texas, 78229
Apex Research Institute
Santa Ana, California, 92705
Cardiovascular Center of Sarasota
Sarasota, Florida, 34231
Cardiovascular Consultants of Maine
Scarborough, Maine, 04074
Medical Research Institute
Slidell, Louisiana, 70458
Liberty Research Center
Tacoma, Washington, 98405
Tampa Bay Nephrology Associates, PL
Tampa, Florida, 33603
Canyon Clinical Research
Tucson, Arizona, 85712
Castlerock Clinical Research Consultants
Tulsa, Oklahoma, 74136
MedStar Diabetes Institute at Washington Hospital Center
Washington D.C., District of Columbia, 20010
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401
Argentina8 sites
CIMEL
Buenos Aires
DIM (Clinica Privada)
Buenos Aires
Fundapres
Buenos Aires
Hospital Britanico de Buenos Aires
Buenos Aires
Hospital Jose Maria Ramos Meijia
Buenos Aires
Hospital Municipal Bernardo Houssay
Buenos Aires
Medeos
Buenos Aires
Sanatorio Municipal
Buenos Aires
France3 sites
CIC Hopital Jeanne D'Arc
Dommartin-lès-Toul
CHU de Grenoble
Grenoble
Hôpital Civil, Service HTA maladies vasculaires
Strasbourg
United Kingdom3 sites
Townhead Surgery
Scotland
Avenue Surgery
Wiltshire
Hathaway Medical Centre
Wiltshire
Brazil2 sites
Centro Integrado Hospital do Rim e Hipertensao
São Paulo
Centro Integrado Hospital
São Paulo
Canada2 sites
Cambridge Cardiac Care Center
Cambridge, Ontario, N3H 3R8
Clinical Research Solutions
Kitchener, Ontario, N2G 1G5
Sweden2 sites
Cardiovascular Research, Karolinska Institue
Stockholm
University Hospital Umea
Umeå
About this study
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)
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.
- Conditions
- Hypertension
- Being tested
- Darusentan
- Keywords
- Resistant Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarusentanDrug
Darusentan capsules administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Darusentan 50 mg | Experimental | Darusentan 50 mg administered orally once daily Receives: Drug: Darusentan |
| Darusentan 100 mg | Experimental | Darusentan 100 mg administered orally once daily Receives: Drug: Darusentan |
| Darusentan 300 mg | Experimental | Darusentan 300 mg administered orally once daily Receives: Drug: Darusentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trough sitting systolic and diastolic blood pressure
Measured: Baseline to Week 14
Secondary outcomes (3)
Change in mean 24-hour systolic and diastolic ambulatory blood pressures.
Measured: Baseline to Week 14
Percentage of subjects who reach systolic blood pressure goal
Measured: Week 14
Change in estimated glomerular filtration rate (eGFR)
Measured: Baseline to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2006 (estimated)
- Study startSep 2006
- Primary completionFeb 2010
- Study completionApr 2010
Why it stopped: Study DAR-312 did not meet primary co-endpoints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353574
- Sponsor's protocol ID
- DAR-311-E
- Acronym
- Darusentan
- Status last verified
- Feb 2014
- First submitted
- 17 Jul 2006
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00353574
- Acronym / sponsor ID
- Darusentan / DAR-311-E
- Conditions
- Hypertension
- Keywords
- Resistant Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study DAR-312 did not meet primary co-endpoints
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 18 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Darusentan 50 mg | Experimental | Drug: DarusentanDarusentan 50 mg administered orally once daily |
| Darusentan 100 mg | Experimental | Drug: DarusentanDarusentan 100 mg administered orally once daily |
| Darusentan 300 mg | Experimental | Drug: DarusentanDarusentan 300 mg administered orally once daily |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DarusentanDarusentan capsules administered orally once daily | Drug | Darusentan 100 mg, Darusentan 300 mg, Darusentan 50 mg |
Primary outcome
Change in trough sitting systolic and diastolic blood pressure
Time frame: Baseline to Week 14
3 secondary outcomes
Change in mean 24-hour systolic and diastolic ambulatory blood pressures.
Time frame: Baseline to Week 14
Percentage of subjects who reach systolic blood pressure goal
Time frame: Week 14
Change in estimated glomerular filtration rate (eGFR)
Time frame: Baseline to Week 14
Results and safety
The study was stopped early (reason given: Study DAR-312 did not meet primary co-endpoints). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
75 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Darusentan in people with Hypertension, run by Gilead Sciences at 75 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Argentina, France, United Kingdom, Brazil and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study DAR-312 did not meet primary co-endpoints). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in trough sitting systolic and diastolic blood pressure (time frame: Baseline to Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.