A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

NCT01204853 | Terminated Phase 3 Results DMC

• 1 other identifier: B1321052
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension, Pulmonary

Keywords

sitaxentan sodium hypertension

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events

  Number of participants with any adverse events, severe adverse events, serious adverse events

  12 weeks

• Change From Baseline in 6-minute Walk Distance

  Change from baseline in 6-minute walk distance is calculated as the value at Week 12 minus value at baseline.

  12 weeks

Secondary Outcomes (5)

• Change From Baseline in WHO Functional Class

  12 weeks

• Number of Participants With Haemodynamics Parameters

  12 weeks

• Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)

  12 weeks

• Clinical Worsening

  12 weeks

• 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

Study Arms (1)

Sitaxentan treatment

EXPERIMENTAL

Drug: Sitaxentan

Interventions

Sitaxentan DRUG

sitaxentan sodium 100 mg

Sitaxentan treatment

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a current diagnosis of symptomatic PAH
• Has 6MWT distances from 150 to 450 meters and distance

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Location

Pfizer Investigational Site

Shinjyuku-ku, Tokyo, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

sitaxsentan

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: September 17, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 1, 2011
• Results First Posted: December 1, 2011

Record last verified: 2011-10

Locations

JP (2)