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Tezosentan in Pulmonary Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT01077297
Recruitment Status : Terminated (Due to slow recruitment, the study was prematurely discontinued)
First Posted : March 1, 2010
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Tracking Information
First Submitted Date  ICMJE February 25, 2010
First Posted Date  ICMJE March 1, 2010
Last Update Posted Date July 9, 2018
Study Start Date  ICMJE August 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2010)
Change in PVR from Baseline to 30 minutes expresses as percent of the Baseline value. [ Time Frame: 30 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2010)
  • Change in mean right arterial pressure (mRAP) from Baseline to 30 minutes [ Time Frame: 30 minutes ]
  • Change in mPAP from Baseline to 30 min [ Time Frame: 30 minutes ]
  • Change in total pulmonary resistance (TPR) from Baseline to 30 min [ Time Frame: 30 minutes ]
  • Change in PCWP from Baseline to 30 min [ Time Frame: 30 minutes ]
  • Change in cardiac output (CO) from Baseline to 30 min [ Time Frame: 30 minutes ]
  • Change in cardiac index (CI) from Baseline to 30 min [ Time Frame: 30 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tezosentan in Pulmonary Arterial Hypertension
Official Title  ICMJE Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines
Brief Summary Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE Drug: Tezosentan
single infusion of tezosentan 5mg/h over 30 min corresponding to 2.5 mg
Study Arms  ICMJE Experimental: Tezosentan
Intervention: Drug: Tezosentan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 27, 2012)
3
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2010)
13
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed informed consent
  2. Male and female patients 18 years of age or older
  3. Patients with PAH according to one of the following subgroups of the Venice Classification Group 1:

    • Idiopathic (iPAH), or
    • Familial/heritable (FPAH), or
    • Associated (APAH) with collagen vascular disease
  4. Modified NYHA functional class II-III
  5. Documented hemodynamic diagnosis of PAH by right heart catheterization at Baseline:

    • Resting mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
    • Resting mean PVR ≥ 240 dyn•s•cm-5 and
    • Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg

Exclusion Criteria:

  1. Patients with PAH in Venice Classification Groups 2-5, and PAH Group 1 subgroups not covered by inclusion criterion no. 3
  2. Hypotensive patients (systemic systolic blood pressure < 100 mmHg)
  3. Patients with body weight < 50 kg (110 lbs)
  4. Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
  5. Patients with clinically significant chronic renal insufficiency (serum creatinine > 2.5mg/dL / 221µmol/L)
  6. Patients who have received any endothelin receptor antagonist (ERA) and/or any phosphodiesterase-5 (PDE-5) inhibitor within 28 days of Baseline
  7. Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost) within 28 days of Baseline
  8. Patients who have received any investigational drugs within 28 days of Baseline
  9. Patients who have received cyclosporine A or tacrolimus within 28 days of Baseline
  10. Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with the study
  11. Life expectancy less than 12 months
  12. Females who are lactating or pregnant or females who are not using a reliable method of birth control (failure rate less than 1% per year) during the study and for at least one month after study drug intake
  13. Known hypersensitivity to any of the excipients of the drug formulation
  14. Patients with positive response to vasoreactivity test
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01077297
Other Study ID Numbers  ICMJE AC-051-206
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Idorsia Pharmaceuticals Ltd.
Study Sponsor  ICMJE Idorsia Pharmaceuticals Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Elisabet Lindberg, MD Actelion
PRS Account Idorsia Pharmaceuticals Ltd.
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP