Trial Outcomes & Findings for Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety (NCT NCT00796510)

NCT ID: NCT00796510

Last Updated: 2018-10-25

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 3 participants
• Primary outcome timeframe: Baseline and every 12 weeks up to Week 18
• Results posted on: 2018-10-25

Participant Flow

Participants were previously enrolled in B1321001 (NCT00795639) or B1321003 (NCT00796666) only where pre-specified entry criteria were met.

Participant milestones

Measure	Sitaxsentan Sitaxsentan 100 milligrams (mg) orally once a day	Sitaxsentan and Sildenafil Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
Overall Study STARTED	3	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Sitaxsentan Sitaxsentan 100 milligrams (mg) orally once a day	Sitaxsentan and Sildenafil Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
Overall Study Death	1	0
Overall Study Study Terminated	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Sitaxsentan n=3 Participants Sitaxsentan 100 milligrams (mg) orally once a day	Sitaxsentan and Sildenafil Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day	Total n=3 Participants Total of all reporting groups
Age, Continuous	42.3 years n=5 Participants	—	42.3 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and every 12 weeks up to Week 18

Population: Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.

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).

Outcome measures

Outcome data not reported

Adverse Events

Sitaxsentan

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Sitaxsentan and Sildenafil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sitaxsentan n=3 participants at risk Sitaxsentan 100 milligrams (mg) orally once a day	Sitaxsentan and Sildenafil Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
Cardiac disorders Cardiac arrest	33.3% 1/3 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	— 0/0 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cytolytic hepatitis	33.3% 1/3 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	— 0/0 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	Sitaxsentan n=3 participants at risk Sitaxsentan 100 milligrams (mg) orally once a day	Sitaxsentan and Sildenafil Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
General disorders Non-cardiac chest pain	33.3% 1/3 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	— 0/0 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	33.3% 1/3 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	— 0/0 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in jaw	33.3% 1/3 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	— 0/0 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER