DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension (Darusentan)

February 19, 2014 updated by: Gilead Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
282

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • CIMeL
      • Buenos Aires, Argentina
        • DIM (Clinica Privada)
      • Buenos Aires, Argentina
        • Fundapres
      • Buenos Aires, Argentina
        • Hospital Británico de Buenos Aires
      • Buenos Aires, Argentina
        • Hospital Jose Maria Ramos Meijia
      • Buenos Aires, Argentina
        • Hospital Municipal bernardo Houssay
      • Buenos Aires, Argentina
        • Medeos
      • Buenos Aires, Argentina
        • Sanatorio Municipal
  • Brazil
      • Sao Paulo, Brazil
        • Centro Integrado Hospital do Rim e Hipertensao
      • Sao Paulo, Brazil
        • Centro integrado hospital
  • Canada
    • Ontario
      • Cambridge, Ontario, Canada, N3H 3R8
        • Cambridge Cardiac Care Center
      • Kitchener, Ontario, Canada, N2G 1G5
        • Clinical Research Solutions
  • Denmark
      • Hvidovre, Denmark
        • Hvidovre Hospital
      • København, Denmark
        • Bispebjerg Hospital
  • France
      • Dommartin les Toul, France
        • CIC Hopital Jeanne D'Arc
      • Grenoble Cedex, France
        • CHU de GRENOBLE
      • Strasbourg Cedex, France
        • Hôpital Civil, Service HTA maladies vasculaires
  • Sweden
      • Stockholm, Sweden
        • Cardiovascular Research, Karolinska Institue
      • Umea, Sweden
        • University Hospital Umeå
  • United Kingdom
      • Scotland, United Kingdom
        • Townhead Surgery
      • Wiltshire, United Kingdom
        • Avenue Surgery
      • Wiltshire, United Kingdom
        • Hathaway Medical Centre
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Comprehensive Heart Failure Center
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Canyon Clinical Research
    • California
      • Inglewood, California, United States, 90301
        • Chrishard Medical Group
      • Los Angeles, California, United States, 90073
        • VA Medical Center - WLA
      • Sacramento, California, United States, 95825
        • Sacramento Heart and Vascular
      • Santa Ana, California, United States, 92705
        • Apex Research Institute
    • Colorado
      • Denver, Colorado, United States, 80220
        • Complete Renal Care
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Connecticut Clinical Research, Llc
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Diabetes Institute at Washington Hospital Center
    • Florida
      • Fort Walton Beach, Florida, United States, 32569
        • White-Wilson Medical Center
      • Hialeah, Florida, United States, 33012
        • A.G.A. Clinical Trials
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical
      • Jupiter, Florida, United States, 33458
        • Ricardo A. Bedoya, Cardiology
      • Miami, Florida, United States, 33156
        • International Research Association
      • Sarasota, Florida, United States, 34231
        • Cardiovascular Center of Sarasota
      • Tampa, Florida, United States, 33603
        • Tampa Bay Nephrology Associates, PL
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute, Inc.
    • Georgia
      • Calhoun, Georgia, United States, 30701
        • Global Research Partners
    • Hawaii
      • Honolulu, Hawaii, United States, 96816
        • Kula Research
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Chicago Heart & Vein Clinic
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Healthcare
      • Gurnee, Illinois, United States, 60031
        • Clinical Investigation Specialists, Inc.
      • Lombard, Illinois, United States, 60148
        • Midwest Heart Foundation
    • Louisiana
      • Slidell, Louisiana, United States, 70458
        • Medical Research Institute
    • Maine
      • Auburn, Maine, United States, 04210
        • Maine Research Associate
      • Auburn, Maine, United States, 04210
        • Androscoggin Cardiology Associates
      • Scarborough, Maine, United States, 04074
        • Cardiovascular Consultants of Maine
    • Maryland
      • Reisterstown, Maryland, United States, 21136
        • Clinical Associates
      • Rockville, Maryland, United States, 20854
        • Rockville Internal Medicine Group
    • Michigan
      • Benzonia, Michigan, United States, 49616
        • Professional Clinical Research
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Interlochen, Michigan, United States, 49643
        • Professional Clinical Research
    • Nevada
      • Pahrump, Nevada, United States, 89048
        • Specialty Medical Center
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Physicians East, PA
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Clinical Trial Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73003
        • Cor Clinical Research
      • Oklahoma City, Oklahoma, United States, 73109
        • Southwest Cardiology Associates
      • Tulsa, Oklahoma, United States, 74136
        • Castlerock Clinical Research Consultants
    • Oregon
      • Hillsboro, Oregon, United States, 97123
        • Hillsboro Cardiology, PC
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Northeast Clinical Research Centers, Inc.
      • Camp Hill, Pennsylvania, United States, 17011
        • Heritage Cardiology Associates
      • Downingtown, Pennsylvania, United States, 19335
        • Brandywine Clinical Research
      • Lansdale, Pennsylvania, United States, 19446
        • Green and Seidner Family Practice Associates
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • RI Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Neem Research Group, Inc.
    • Texas
      • Desoto, Texas, United States, 75115
        • Internal Medicine & Industrial Medicine
      • Ft Worth, Texas, United States, 76117
        • T&R Clinical, P.A.
      • Lewisville, Texas, United States, 75067
        • Pri-Med Care
      • San Antonio, Texas, United States, 78229
        • Innovative Clinical Trials
    • Virginia
      • Burke, Virginia, United States, 22015
        • Burke Internal Medicine, Inc.
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center
    • Washington
      • Tacoma, Washington, United States, 98405
        • Liberty Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Darusentan 50 mg
Darusentan 50 mg administered orally once daily
Drug: Darusentan
Darusentan capsules administered orally once daily
EXPERIMENTAL: Darusentan 100 mg
Darusentan 100 mg administered orally once daily
Drug: Darusentan
Darusentan capsules administered orally once daily
EXPERIMENTAL: Darusentan 300 mg
Darusentan 300 mg administered orally once daily
Drug: Darusentan
Darusentan capsules administered orally once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in trough sitting systolic and diastolic blood pressure
Time Frame: Baseline to Week 14
Baseline to Week 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in mean 24-hour systolic and diastolic ambulatory blood pressures.
Time Frame: Baseline to Week 14
Baseline to Week 14
Percentage of subjects who reach systolic blood pressure goal
Time Frame: Week 14
Week 14
Change in estimated glomerular filtration rate (eGFR)
Time Frame: Baseline to Week 14
Baseline to Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2006

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2006

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DAR-311-E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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