A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
- Registration Number
- NCT01204853
- Lead Sponsor
- Pfizer
- Brief Summary
The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU, Canada and Australia. In this study, the safety and efficacy after administrations of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be investigated in Japanese PAH patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- Has a current diagnosis of symptomatic PAH
- Has 6MWT distances from 150 to 450 meters and distance
- Previous exposure to an endothelin receptor antagonist
- Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure >160 mm Hg or sitting diastolic blood pressure >100 mm Hg at Screening.
- Has hypotension defined as systolic arterial pressure <90 mm Hg after sitting for 5 minutes at Screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sitaxentan treatment Sitaxentan -
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events 12 weeks Number of participants with any adverse events, severe adverse events, serious adverse events
Change From Baseline in 6-minute Walk Distance 12 weeks Change from baseline in 6-minute walk distance is calculated as the value at Week 12 minus value at baseline.
- Secondary Outcome Measures
Name Time Method Change From Baseline in WHO Functional Class 12 weeks The change from baseline in WHO functional class was classified into "Improved", "No change" and "Worsened". The change from baseline in WHO functional class at Week 12 was to be summarized with frequency count and percentage in each category based on imputed data for missing values at Week 12.
Number of Participants With Haemodynamics Parameters 12 weeks The following haemodynamic measurements were assessed: right arterial pressure, pulmonary arterial systolic pressure, pulmonary arterial diastolic pressure, mean pulmonary arterial pressure, pulmonary capillary wedge pressure, left ventricular-end diastolic pressure, cardiac output, systemic arterial blood pressure (systolic, diastolic and mean), and heart rate.
Change from baseline in haemodynamics parameters is calculated as the value at Week 12 minus value at baseline.Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP) 12 weeks Change from baseline in NT-pro BNP is calculated as the value at Week 12 minus value at baseline.
Clinical Worsening 12 weeks Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen.
Number of Participants With Pharmacokinetic (PK) Parameters at Steady State pre-dose at Week 2, 4, 8, and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose at Week 12 or study termination The following PK parameters at the steady state were evaluated: maximum observed concentration during the dosing interval (Cmax), time for maximum observed concentration during the dosing interval (Tmax), area under the plasma concentration-time curve over dosing interval tau for multiple dose (AUCtau), terminal elimination half-life (t1/2), apparent clearance (CL/F) and apparent volume of distribution during the terminal elimination phase (Vz/F) at Week 12/Termination (as data permit), and concentration predose during multiple dosing (Ctrough) at Week 2, 4, 8 and 12/Termination.
Trial Locations
- Locations (1)
Pfizer Investigational Site
šÆšµShinjyuku-ku, Tokyo, Japan