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Clinical Trials/EUCTR2006-003547-23-DK
EUCTR2006-003547-23-DKActive, not recruitingPhase 1

DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant HypertensionA Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects with Resistant Hypertension Receiving Combination Therapy with Three or MoreAntihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo - DORADO-AC

Gilead Sciences, Inc.0 sites770 target enrollmentStarted: September 17, 2007Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
770
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Subjects must be competent to provide written informed consent.
  • •2. Subjects must be 35-80 years of age.
  • •3. Subjects must have resistant systolic hypertension consistent with current clinical guidelines for the treatment of hypertension.
  • •4. Subjects with diabetes and/or CKD must have an average sitting SBP =130 mmHg.
  • •5. All other subjects must have an average sitting SBP =140 mmHg.
  • •6. Subjects must be receiving, and adhering to, full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic.
  • •7. Subjects must have a BMI of 20 to 43 kg/m2, inclusive. If BMI >43 kg/m2, the subject must have an upper arm circumference <42 cm at Screening (Visit 1).
  • •8. Subjects must have an eGFR of = 30mL/min/1.73m2 at Screening (Visit 1).
  • •9. Female subjects must be of non-childbearing potential, i.e., documented post-menopausal (cessation of regular menstrual periods) for at least 2 years or surgically sterile (i.e., hysterectomy and/or bilateral oophorectomy).
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1. Subjects with an average sitting SBP of =180 mmHg or DBP of =110 mmHg.
  • •2. Subjects with left ventricular (LV) systolic dysfunction.
  • •3. Subjects with a serum ALT or AST >2xULN.
  • •4. Subjects who have experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the Screening Visit (Visit 1).
  • •5. Subjects with sick sinus syndrome or second or third degree atrioventricular (AV) block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia (including paroxysmal atrial tachycardia), a history of recurrent ventricular tachycardia, or symptomatic bradycardia.
  • •6. Subjects with implanted pacemakers or an implanted cardioverter defibrillator.
  • •7. Subjects with a historical or current diagnosis of symptomatic or asymptomatic CHF, treated or untreated.
  • •8. Subjects with hemodynamically significant valvular heart disease.
  • •9. Subjects with Type 1 diabetes mellitus.
  • •10. Subjects on hemodialysis or peritoneal dialysis at the time of Screening (Visit 1) and subjects with a history of solid organ transplant (e.g., kidney, heart).
  • •11. Subjects who have had a diagnosis or recurrence of malignancy within the past 3 years, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix.
  • •12. Subjects with sleep apnea are excluded, unless a post-treatment sleep study has confirmed treatment efficacy and there are no recordings of blood oxygen saturation (SpO2) <90% at any time during the testing period.
  • •13. Subjects who perform alternating shift or night work.
  • •14. Subjects treated with a central alpha-2 agonist and/or an imidazoline receptor agonist (i.e., guanfacine, clonidine, moxonidine) within 90 days of Screening.
  • •15. Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks of the Screening Visit (Visit 1).
  • •16. Subjects not on stable doses of all concomitant medications for a minimum of 4 weeks prior to Screening (Visit 1), and subjects treated with any protocol-specified prohibited medications (e.g. thiazolidinedione).

Investigators

Similar Trials

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DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant HypertensionA Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects with Resistant Hypertension Receiving Combination Therapy with Three or MoreAntihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo - DORADO-ACResistant hypertension
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DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant HypertensionA Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects with Resistant Hypertension Receiving Combination Therapy with Three or MoreAntihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo - DORADO-ACMedDRA version: 8.1Level: LLTClassification code 10038274Term: Refractory hypertensionResistant hypertension
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DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant HypertensionA Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects with Resistant Hypertension Receiving Combination Therapy with Three or MoreAntihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or PlaceboDORADO-AC: Dosis Óptimas de Darusentan Comparadas con un Control Activo en Hipertensión ResistenteEstudio fase 3, aleatorizado, multicéntrico, doble ciego, controlado con placebo/medicación activa, de grupos paralelos para evaluar la eficacia y seguridad de Darusentan en pacientes con hipertensión resistente que reciben tratamiento combinado con tres o más medicamentos antihipertensivos, incluyendo un diurético, comparado con Guanfacina o placebo - DORADO-ACResistant hypertension
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DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant HypertensionA Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects with Resistant Hypertension Receiving Combination Therapy with Three or MoreAntihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo - DORADO-ACResistant hypertensionMedDRA version: 8.1Level: LLTClassification code 10038274Term: Refractory hypertension
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