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Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety

Primary Purpose

Pulmonary Arterial Hypertension, Pulmonary Hypertension

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Sitaxsentan

Sitaxsentan and Sildenafil

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring endothelin receptor antagonist (ETRA), sitaxsentan

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Previously enrolled in B1321001 for at least 4 weeks.
Previously enrolled in B1321003, discontinued from the study.
Completed the B1321003 study as planned.

Exclusion Criteria:

Treated with an investigational drug (other than sitaxsentan or sildenafil in either B1321001 or B1321003) or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sitaxsentan

Sitaxsentan and Sildenafil

Arm Description

Monotherapy arm

Combination treatment

Outcomes

Primary Outcome Measures

Overall Survival

Overall survival is the duration from first dose to death. For participants who are lost to follow-up, survival was censored at the last date of follow-up.

Secondary Outcome Measures

Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24

The walk distance was the total distance walked during the 6-minute test. Change is distance walked at week x minus distance walked at baseline.

Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH)

The WHO functional classes of PAH range from Class 1 (no limitation in physical activity) to Class IV (can not perform a physical activity without any symptoms).

Full Information

NCT ID

NCT00796510

First Posted

November 20, 2008

Last Updated

September 26, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00796510

Brief Title

Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety

Official Title

A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Terminated

Why Stopped

Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury

Study Start Date

July 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in combination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Arterial Hypertension, Pulmonary Hypertension

Keywords

endothelin receptor antagonist (ETRA), sitaxsentan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sitaxsentan

Arm Type

Experimental

Arm Description

Monotherapy arm

Arm Title

Sitaxsentan and Sildenafil

Arm Type

Experimental

Arm Description

Combination treatment

Intervention Type

Drug

Intervention Name(s)

Sitaxsentan

Intervention Description

Sitaxsentan = 100 mg tablet administered orally, once daily

Intervention Type

Drug

Intervention Name(s)

Sitaxsentan and Sildenafil

Intervention Description

Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day

Primary Outcome Measure Information:

Title

Overall Survival

Description

Overall survival is the duration from first dose to death. For participants who are lost to follow-up, survival was censored at the last date of follow-up.

Time Frame

Baseline and every 12 weeks up to Week 18

Secondary Outcome Measure Information:

Title

Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24

Description

The walk distance was the total distance walked during the 6-minute test. Change is distance walked at week x minus distance walked at baseline.

Time Frame

Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18)

Title

Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH)

Description

The WHO functional classes of PAH range from Class 1 (no limitation in physical activity) to Class IV (can not perform a physical activity without any symptoms).

Time Frame

Baseline, Week 12 and ET (up to Week 18)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Previously enrolled in B1321001 for at least 4 weeks. Previously enrolled in B1321003, discontinued from the study. Completed the B1321003 study as planned. Exclusion Criteria: Treated with an investigational drug (other than sitaxsentan or sildenafil in either B1321001 or B1321003) or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Pfizer Investigational Site

City

Cluj Napoca

ZIP/Postal Code

400 001

Country

Romania

Facility Name

Pfizer Investigational Site

City

Kyiv

Country

Ukraine

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1321002

Description

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

Learn more about this trial

Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety

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