Trial Outcomes & Findings for To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks (NCT NCT00946114)

Last Updated: 2021-02-01

Results Overview

Adverse event = any untoward medical occurrence in a subject administered study medication regardless of causality including abnormal test findings, clinically significant signs/symptoms, changes in physical examination findings, hypersensitivity, progression/worsening of underlying disease, and exposure in utero. Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect.

Recruitment status

COMPLETED

Target enrollment

32 participants

Primary outcome timeframe

Baseline up to 116 Weeks

Results posted on

2021-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	Sildenafil 60 mg Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)	Sildenafil 240 mg Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
Overall Study STARTED	20	12
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sildenafil 60 mg Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)	Sildenafil 240 mg Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
Overall Study Death	5	2
Overall Study Other	1	0
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sildenafil 60 mg n=20 Participants Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)	Sildenafil 240 mg n=12 Participants Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142	Total n=32 Participants Total of all reporting groups
Age, Customized 18 - 44 years	10 participants n=5 Participants	6 participants n=7 Participants	16 participants n=5 Participants
Age, Customized 45 - 64 years	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants
Age, Customized >= 65 years	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	9 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 116 Weeks

Population: Safety population: all subjects assumed to have taken at least one dose of study medication. Non-serious adverse events were reported up to 7 days after the last dose of study medication. Serious adverse events were reported up to 28 days after the last dose of study medication.

Outcome measures

Outcome measures
Measure	Sildenafil 60 mg n=20 Participants Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)	Sildenafil 240 mg n=12 Participants Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	11 participants	8 participants
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	8 participants	2 participants

Adverse Events

Sildenafil 60 mg

Serious events: 8 serious events

Other events: 11 other events

Deaths: 0 deaths

Sildenafil 240 mg

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sildenafil 60 mg n=20 participants at risk Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)	Sildenafil 240 mg n=12 participants at risk Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
Cardiac disorders Cardiac arrest	5.0% 1/20 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/12 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac failure	15.0% 3/20 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/12 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Supraventricular tachycardia	5.0% 1/20 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/12 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Retinal vein thrombosis	5.0% 1/20 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/12 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Sudden cardiac death	0.00% 0/20 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 2/12 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Syncope	5.0% 1/20 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/12 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.0% 1/20 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/12 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.0% 1/20 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/12 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	5.0% 1/20 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/12 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	5.0% 1/20 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/12 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Peripheral embolism	5.0% 1/20 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/12 • Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER