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DORADO - Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT00330369
Collaborator
(none)
352
Enrollment
115
Locations
4
Arms
31
Duration (Months)
3.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the U.S. Food and Drug Administration (FDA) for use in the United States, which means that a doctor cannot prescribe this drug. The purpose of this study is to determine if darusentan is effective in reducing systolic blood pressure in subjects with resistant systolic hypertension, despite treatment with full doses of three or more antihypertensive drugs, including a diuretic.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
352 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
DORADO - A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety 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)
Study Start Date :
Jun 1, 2006
Actual Primary Completion Date :
Jan 1, 2009
Actual Study Completion Date :
Jan 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Darusentan Placebo

Placebo to match darusentan for 2-week placebo run-in period, followed by placebo to match darusentan administered orally once daily for 14 weeks

Drug: Darusentan Placebo
Placebo to match darusentan administered orally once daily
Experimental: Darusentan 50 mg

Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 50 mg administered orally once daily for 14 weeks

Drug: Darusentan
Darusentan administered orally once daily
Other Names:
  • LU 135252

    • Drug: Darusentan Placebo
    Placebo to match darusentan administered orally once daily
    Experimental: Darusentan 100 mg

    Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 100 mg administered orally once daily for 14 weeks

    Drug: Darusentan
    Darusentan administered orally once daily
    Other Names:
  • LU 135252

    • Drug: Darusentan Placebo
    Placebo to match darusentan administered orally once daily
    Experimental: Darusentan 300 mg

    Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 300 mg administered orally once daily for 14 weeks

    Drug: Darusentan
    Darusentan administered orally once daily
    Other Names:
  • LU 135252

    • Drug: Darusentan Placebo
    Placebo to match darusentan administered orally once daily

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry [Baseline to Week 14]

    Secondary Outcome Measures

    1. Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure [Baseline to Week 14]

    2. Percentage of subjects to reach systolic blood pressure goal [Week 14]

    3. Change from baseline in estimated glomerular filtration rate (eGFR) [Baseline to Week 14]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects who are competent to provide written consent

    • Aged 35 to 80 years

    • Subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmHg

    • All other subjects must have a mean systolic blood pressure ≥140 mmHg

    • Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic

    • Female subjects of non-childbearing potential (i.e., post-menopausal for at lest 2 years; surgically sterile)

    Exclusion Criteria:

    • Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg

    • Serum ALT or AST >2 x the upper limit of the normal range (ULN)

    • Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident (CVA) within 6 month; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia

    • Implanted pacemakers or implanted cardioverter defibrillator (ICD)

    • Symptomatic congestive heart failure requiring treatment

    • Hemodynamically significant valvular heart disease

    • Type I diabetes mellitus

    • Hemodialysis or peritoneal dialysis; or history of renal transplant

    • Diagnosis or recurrence of malignancy within the past 3 years

    • Sleep apnea, unless a recent sleep study demonstrates arterial oxygen saturation greater than or equal to 90%

    • Subjects who perform alternating shift or night work

    • Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UAB Hypertension Program Birmingham Alabama United States 35294
    2 Comprehensive Heart Failure Center Mobile Alabama United States 36608
    3 Canyon Clinical Research Tucson Arizona United States 85712
    4 Chrishard Medical Group Inglewood California United States 90301
    5 VA Medical Center - WLA Los Angeles California United States 90073
    6 Sacramento Heart and Vascular Sacramento California United States 95825
    7 Apex Research Institute Santa Ana California United States 92705
    8 Complete Renal Care Denver Colorado United States 80220
    9 Connecticut Clinical Research, LLC Bridgeport Connecticut United States 06606
    10 MedStar Diabetes Institute at Washington Hospital Center Washington District of Columbia United States 20010
    11 Deerfield Beach Cardiology Associates Deerfield Beach Florida United States 33442
    12 White-Wilson Medical Center Fort Walton Beach Florida United States 32569
    13 AMK Research Gainsville Florida United States 32601
    14 A.G.A. Clinical Trials Hialeah Florida United States 33012
    15 Jacksonville Center for Clinical Jacksonville Florida United States 32216
    16 Ricardo A. Bedoya, Cardiology Jupiter Florida United States 33458
    17 International Research Association Miami Florida United States 33156
    18 Cardiovascular Center of Sarasota Sarasota Florida United States 34239
    19 Tampa Bay Nephrology Tampa Florida United States 33603
    20 Metabolic Research Institute, Inc. West Palm Beach Florida United States 33401
    21 Global Research Partners Calhoun Georgia United States 30701
    22 Kula Research Honolulu Hawaii United States 96816
    23 Chicago Heart & Vein Clinic Elk Grove Village Illinois United States 60007
    24 Evanston Northwestern Healthcare Evanston Illinois United States 60201
    25 Clinical Investigation Specialists, Inc. Gurnee Illinois United States 60031
    26 Midwest Heart Foundation Lombard Illinois United States 60148
    27 American Clinical Research LLC Marrero Louisiana United States 70072
    28 Medical Research Institute Slidell Louisiana United States 70458
    29 Maine Research Associates Auburn Maine United States 04210
    30 Cardiovascular Consultants of Maine Scarborough Maine United States 04074
    31 MODEL Clinical Research Baltimore Maryland United States 21204
    32 Maryland Medical Research/Og Medical Center Oxon Hill Maryland United States 20745
    33 Clinical Associates Reisterstown Maryland United States 21136
    34 Rockville Internal Medicine Group Rockville Maryland United States 20854
    35 Professional Clinical Research Benzonia Michigan United States 49616
    36 Nephrology and Hypertension / Hurley Medical Center Flint Michigan United States 48503
    37 Professional Clinical Research Interlochen Michigan United States 49643
    38 Specialty Medical Center Pahrump Nevada United States 89048
    39 Bronx VA Medical Center / Mt. Sinai Bronx New York United States 10468
    40 Physicians East, PA Greenville North Carolina United States 27834
    41 The Lindner Clinical Trial Center Cincinnati Ohio United States 45219
    42 West Coast Cardiology Associates Fairview Park Ohio United States 44125
    43 COR Clinical Research Oklahoma City Oklahoma United States 73003
    44 Southwest Cardiology Associates Oklahoma City Oklahoma United States 73109
    45 Sooner Clinical Research Oklahoma City Oklahoma United States 73112
    46 Castlerock Clinical Research Consultants Tulsa Oklahoma United States 74136
    47 Hillsboro Cardiology, PC Hillsboro Oregon United States 97123
    48 Northeast Clinical Research Centers, Inc. Allentown Pennsylvania United States 18103
    49 Heritage Cardiology Associates Camp Hill Pennsylvania United States 17011
    50 Brandywine Clinical Research Downingtown Pennsylvania United States 19335
    51 Green and Seidner Family Practice Associates Lansdale Pennsylvania United States 19446
    52 Temple University Hospital Philadelphia Pennsylvania United States 19140
    53 RI Hospital Providence Rhode Island United States 02903
    54 Neem Research Group, Inc. Columbia South Carolina United States 29201
    55 Internal Medicine & Industrial Medicine Desoto Texas United States 75115
    56 T&R Clinical, P.A. Ft Worth Texas United States 76117
    57 Pri-Med Care Lewisville Texas United States 75067
    58 Texas Tech University Health Sciences Center Lubbock Texas United States 79430
    59 Diabetes Center of the Southwest Midland Texas United States 79705
    60 The Bracane Company Plano Texas United States 75093
    61 Innovative Clinical Trials San Antonio Texas United States 78229
    62 Burke Internal Medicine, Inc. Burke Virginia United States 22015
    63 Manassas Clinical Research Center Manassas Virginia United States 20110
    64 McGuire VA Medical Center Richmond Virginia United States 22015
    65 Peninsula Inernal Medicine Gig Harbor Washington United States 98335
    66 Liberty Research Center Tacoma Washington United States 98405
    67 CAMC Clinical Trials Center Charleston West Virginia United States 25304
    68 CIMEL Buenos Aires Argentina
    69 DIM (Clinica Privada) Buenos Aires Argentina
    70 Fundapres Buenos Aires Argentina
    71 Hospital Britanico de Buenos Aires Buenos Aires Argentina
    72 Hospital Jose Maria Ramos Meijia Buenos Aires Argentina
    73 Hospital Municipal bernardo Houssay Buenos Aires Argentina
    74 Medeos Buenos Aires Argentina
    75 Sanatorio Municipal Dr. Julio Mendez Buenos Aires Argentina
    76 Clinica Chutro SRL Cordoba Argentina
    77 Hospital San Roque Cordoba Argentina
    78 Hospital Governador Israel Pinheiro Belo Horizonte Brazil
    79 Hospital Socor Belo Horizonte Brazil
    80 Centro Medico de Campinas Campinas Brazil
    81 Hospital de Clinicas da Universidade Federal do Parana Curitiba Brazil
    82 Hospital das Clinicas Goiânia Brazil
    83 Clinica de Exames Maceió Brazil
    84 Centro Integrado Hospital do Rim e Hipertensao Sao Paulo Brazil
    85 Centro integrado hospital Sao Paulo Brazil
    86 Hospital das Clinicas da Faculdade de Medicina da USP Sao Paulo Brazil
    87 Instituto de Molestias São José do Rio Preto Brazil
    88 Cambridge Cardiac Care Center Cambridge Ontario Canada N3H 3R8
    89 Clinical Research Solutions Kitchener Ontario Canada N2G 1G5
    90 Hvidovre Hospital Hvidovre Denmark
    91 Bispebjerg Hospital København Denmark
    92 CIC Hopital Jeanne D'Arc Dommartin les Toul France
    93 CHU de Grenoble Grenoble Cedex France
    94 CHU la Timone Service de cardiologie Marseille Cedex France
    95 CHU Victor Provo Roubaix France
    96 Hôpital Civil, Service HTA maladies vasculaires Strasbourg Cedex France
    97 Kerckhoff-Klinik Forschungs GmbH Bad Nauheim Germany
    98 Charité Campus Buch Berlin Germany
    99 St Josefs-Hospital Cloppenburg Germany
    100 Medizinische Hochschule Hannover Hannover Germany
    101 Universitätsklinikum Schleswig-Holstein Lübeck Germany
    102 Azienda Ospedaliera University of Padua Policlinico Padua Italy
    103 Fundacio Puigvert Barcelona Spain
    104 Hospital Clinic i Provincial Barcelona Spain
    105 Hospital del Mar Barcelona Spain
    106 Hospital Universitario de Santiago Coruña Spain
    107 Hospital Clínico San Cecilio Granada Spain
    108 Hospital Clínico de San Carlos Madrid Spain
    109 Hospital Universitario 12 de Octobre Madrid Spain
    110 Hospital Carlos Haya Malaga Spain
    111 Cardiovascular Research, Karolinska Institue Stockholm Sweden
    112 Stonehill Medical Centre Bolton, United Kingdom
    113 Townhead Surgery Scotland United Kingdom
    114 Avenue Surgery Wiltshire United Kingdom
    115 Hathaway Medical Centre Wiltshire United Kingdom

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT00330369
    Other Study ID Numbers:
    • DAR-311
    First Posted:
    May 26, 2006
    Last Update Posted:
    Mar 18, 2014
    Last Verified:
    Feb 1, 2014
    Additional relevant MeSH terms:
    Hypertension
    Darusentan

    Study Results

    No Results Posted as of Mar 18, 2014