Tezosentan in Pulmonary Arterial Hypertension | NCT01077297

Studies
Tezosentan in Pulmonary Arterial Hypertension

NCT01077297

Sponsor

Idorsia Pharmaceuticals Ltd.

Status

Terminated

Last Update Posted

Jul 9, 2018Actual

Enrollment

3Actual

Phase

Phase 2

Conditions

Pulmonary Arterial Hypertension

Interventions

Tezosentan

Countries

United States
France
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to slow recruitment, the study was prematurely discontinued

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Sep 2011Actual

First Submitted Date

Feb 25, 2010

First Submission Date that Met QC Criteria

Feb 26, 2010

First Posted Date

Mar 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jul 13, 2012

Certification/Extension First Submitted that Passed QC Review

Jul 13, 2012

Certification/Extension First Posted Date

Jul 23, 2012Estimated

Last Update Submitted Date

Jul 6, 2018

Last Update Posted Date

Jul 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Label	Type	Description	Intervention Names
Tezosentan	Experimental		Drug: Tezosentan

Name	Type	Description	Arm Group Labels	Other Names
Tezosentan	Drug	single infusion of tezosentan 5mg/h over 30 min corresponding to 2.5 mg	Tezosentan

Measure	Description	Time Frame
Change in PVR from Baseline to 30 minutes expresses as percent of the Baseline value.		30 minutes

Measure	Description	Time Frame
Change in mean right arterial pressure (mRAP) from Baseline to 30 minutes		30 minutes
Change in mPAP from Baseline to 30 min		30 minutes
Change in total pulmonary resistance (TPR) from Baseline to 30 min

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent
Male and female patients 18 years of age or older
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
Modified NYHA functional class II-III
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:

Patients with PAH in Venice Classification Groups 2-5, and PAH Group 1 subgroups not covered by inclusion criterion no. 3
Hypotensive patients (systemic systolic blood pressure < 100 mmHg)
Patients with body weight < 50 kg (110 lbs)
Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
Patients with clinically significant chronic renal insufficiency (serum creatinine > 2.5mg/dL / 221µmol/L)
Patients who have received any endothelin receptor antagonist (ERA) and/or any phosphodiesterase-5 (PDE-5) inhibitor within 28 days of Baseline
Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost) within 28 days of Baseline
Patients who have received any investigational drugs within 28 days of Baseline
Patients who have received cyclosporine A or tacrolimus within 28 days of Baseline
Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with the study
Life expectancy less than 12 months
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
Known hypersensitivity to any of the excipients of the drug formulation
Patients with positive response to vasoreactivity test

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States
Baylor College of Medicine

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases