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Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil

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 (NCT00795639) and completed the 12-week study as planned.

Exclusion Criteria:

Treated with an investigational drug, other than sitaxsentan sodium in B1321001 (NCT00795639), or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sitaxsentan and Placebo

Sitaxsentan and Sildenafil

Arm Description

Monotherapy arm

Combination treatment

Outcomes

Primary Outcome Measures

Time to Clinical Worsening (TTCW)

Clinical worsening defined as time between first dose of study drug and occurrence of death; or heart-lung/lung transplant; or hospitalization for worsening pulmonary atrial hypertension (PAH); or atrial septostomy; or withdrawal due to addition of chronic medications for treatment of worsening PAH: prostacyclin/prostacyclin analogues/phosphodiesterase-5inhibitors/alternative endothelin receptor antagonists/intravenous inotropes; or increase of calcium channel blockers or oxygen. TTCW measured as duration between study's first dose date in and date when first clinical worsening event occurs.

Secondary Outcome Measures

Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD)

6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change from baseline = score at Week x - score at baseline.

Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48

WHO PAH Functional Classification of physical activity limitations: I (no limitation), II (slight limitation), III (marked limitations, comfortable at rest) and IV (unable to carry out any physical activity without symptoms). The change from baseline in WHO class was classified as Improved (decrease in functional class), No Change (functional class stayed the same), and Worsened (functional class increased). The change from baseline in WHO functional class at Week X was summarized with frequency count and percentage in each category based on imputed data for missing values at Week X.

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning Domain

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Physical Functioning score at Week x minus score at baseline.

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitations Due to Physical Health Problems Domain

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Physical Health Problems score at Week x minus score at baseline.

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Bodily Pain Domain

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Bodily Pain score at Week x minus score at baseline.

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - General Health Domain

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = General Health score at Week x minus score at baseline.

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Vitality Domain

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Social Functioning Domain

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Social Functioning score at Week x minus score at baseline.

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitation Due to Emotional Problems Domain

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Emotional Problems score at Week x minus score at baseline.

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Mental Health Domain

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Mental Health score at Week x minus score at baseline.

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Mental Health

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Mental Health score at Week x minus score at baseline.

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Physical Health

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Physical Health score at Week x minus score at baseline.

Full Information

NCT ID

NCT00796666

First Posted

November 20, 2008

Last Updated

March 4, 2015

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00796666

Brief Title

Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil

Official Title

A Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 (NCT00795639)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

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

May 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safety/efficacy database of the combination is limited.

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

ParticipantInvestigator

Allocation

Randomized

Enrollment

131 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sitaxsentan and Placebo

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 Sildenafil placebo = 1 tablet administered orally, three times a day

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

Time to Clinical Worsening (TTCW)

Description

Time Frame

Baseline, Weeks 12, 24 or Early Termination (ET)

Secondary Outcome Measure Information:

Title

Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD)

Description

Time Frame

Baseline to Weeks 12 and 24

Title

Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48

Description

Time Frame

Baseline, Weeks 12, 24 or ET

Title

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning Domain

Description

Time Frame

Baseline, Weeks 12, 24 and ET

Title

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitations Due to Physical Health Problems Domain

Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Physical Health Problems score at Week x minus score at baseline.

Time Frame

Baseline, Weeks 12, 24 or ET

Title

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Bodily Pain Domain

Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Bodily Pain score at Week x minus score at baseline.

Time Frame

Baseline, Weeks 12, 24 or ET

Title

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - General Health Domain

Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = General Health score at Week x minus score at baseline.

Time Frame

Baseline, Weeks 12, 24 or ET

Title

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Vitality Domain

Description

Time Frame

Baseline, Weeks 12, 24 or ET

Title

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Social Functioning Domain

Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Social Functioning score at Week x minus score at baseline.

Time Frame

Baseline, Weeks 12, 24 or ET

Title

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitation Due to Emotional Problems Domain

Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Emotional Problems score at Week x minus score at baseline.

Time Frame

Baseline, Weeks 12, 24 or ET

Title

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Mental Health Domain

Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Mental Health score at Week x minus score at baseline.

Time Frame

Baseline, Weeks 12, 24 or ET

Title

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Mental Health

Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Mental Health score at Week x minus score at baseline.

Time Frame

Baseline, Weeks 12, 24 or ET

Title

Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Physical Health

Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Physical Health score at Week x minus score at baseline.

Time Frame

Baseline, Weeks 12, 24 or ET

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 (NCT00795639) and completed the 12-week study as planned. Exclusion Criteria: Treated with an investigational drug, other than sitaxsentan sodium in B1321001 (NCT00795639), 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

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Pfizer Investigational Site

City

Weston

State/Province

Florida

ZIP/Postal Code

33331

Country

United States

Facility Name

Pfizer Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Pfizer Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

Pfizer Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Pfizer Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Pfizer Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Pfizer Investigational Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Pfizer Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

Facility Name

Pfizer Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1039AAO

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1428DCO

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1428DUS

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1431FWO

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Temuco

ZIP/Postal Code

4781173

Country

Chile

Facility Name

Pfizer Investigational Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410008

Country

China

Facility Name

Pfizer Investigational Site

City

Beijing

ZIP/Postal Code

100032

Country

China

Facility Name

Pfizer Investigational Site

City

Shanghai

ZIP/Postal Code

200001

Country

China

Facility Name

Pfizer Investigational Site

City

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

Pfizer Investigational Site

City

Bogotá

State/Province

Cundinamarca

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Praha 2

ZIP/Postal Code

128 08

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500 001

Country

India

Facility Name

Pfizer Investigational Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500 063

Country

India

Facility Name

Pfizer Investigational Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380 015

Country

India

Facility Name

Pfizer Investigational Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380 060

Country

India

Facility Name

Pfizer Investigational Site

City

Surat

State/Province

Gujarat

ZIP/Postal Code

395 007

Country

India

Facility Name

Pfizer Investigational Site

City

Vadodara

State/Province

Gujarat

ZIP/Postal Code

390 015

Country

India

Facility Name

Pfizer Investigational Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411 030

Country

India

Facility Name

Pfizer Investigational Site

City

Coimbatore

State/Province

Tamil Nadu

ZIP/Postal Code

641 014

Country

India

Facility Name

Pfizer Investigational Site

City

Madurai

State/Province

Tamil Nadu

ZIP/Postal Code

625 107

Country

India

Facility Name

Pfizer Investigational Site

City

Georgetown

State/Province

Penang

ZIP/Postal Code

10990

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64718

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Pfizer Investigational Site

City

Cluj Napoca

ZIP/Postal Code

400 001

Country

Romania

Facility Name

Pfizer Investigational Site

City

Iasi

ZIP/Postal Code

700 503

Country

Romania

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

105077

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

194156

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Pfizer Investigational Site

City

Johannesburg

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Pfizer Investigational Site

City

Istanbul, Fatih

ZIP/Postal Code

34080

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Kyiv

Country

Ukraine

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1321003&StudyName=Study%20Looking%20at%20Combination%20Therapy%20%28Sitaxsentan+Sildenafil%29%20Vs.%20Monotherapy%20%28Sitaxsentan%20Alone%29%20SR-PAAS%20-Sitaxsentan%20Efficacy%20And%20Safety

Description

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Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil

Pulmonary Arterial Hypertension, Pulmonary Hypertension

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial