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

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ClinicalTrials.gov Identifier: NCT00946114
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : April 16, 2010
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Time Perspective: Prospective
Condition Pulmonary Hypertension
Intervention Drug: sildenafil
Enrollment 32

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sildenafil 60 mg Sildenafil 240 mg
Hide Arm/Group Description Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension) Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
Period Title: Overall Study
Started 20 12
Completed 12 10
Not Completed 8 2
Reason Not Completed
Death             5             2
Other             1             0
Withdrawal by Subject             2             0
Arm/Group Title Sildenafil 60 mg Sildenafil 240 mg Total
Hide Arm/Group Description Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension) Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142 Total of all reporting groups
Overall Number of Baseline Participants 20 12 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 12 participants 32 participants
18 - 44 years 10 6 16
45 - 64 years 8 6 14
>= 65 years 2 0 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 12 participants 32 participants
Female
17
  85.0%
9
  75.0%
26
  81.3%
Male
3
  15.0%
3
  25.0%
6
  18.8%
1.Primary Outcome
Title Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Baseline up to 116 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sildenafil 60 mg Sildenafil 240 mg
Hide Arm/Group Description:
Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
Overall Number of Participants Analyzed 20 12
Measure Type: Number
Unit of Measure: participants
AEs 11 8
SAEs 8 2
Time Frame 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
Adverse Event Reporting Description 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.
 
Arm/Group Title Sildenafil 60 mg Sildenafil 240 mg
Hide Arm/Group Description Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension) Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
All-Cause Mortality
Sildenafil 60 mg Sildenafil 240 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sildenafil 60 mg Sildenafil 240 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   8/20 (40.00%)   2/12 (16.67%) 
Cardiac disorders     
Cardiac arrest  1  1/20 (5.00%)  0/12 (0.00%) 
Cardiac failure  1  3/20 (15.00%)  0/12 (0.00%) 
Supraventricular tachycardia  1  1/20 (5.00%)  0/12 (0.00%) 
Eye disorders     
Retinal vein thrombosis  1  1/20 (5.00%)  0/12 (0.00%) 
General disorders     
Sudden cardiac death  1  0/20 (0.00%)  2/12 (16.67%) 
Nervous system disorders     
Syncope  1  1/20 (5.00%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Haemoptysis  1  1/20 (5.00%)  0/12 (0.00%) 
Hypoxia  1  1/20 (5.00%)  0/12 (0.00%) 
Pulmonary arterial hypertension  1  1/20 (5.00%)  0/12 (0.00%) 
Pulmonary embolism  1  1/20 (5.00%)  0/12 (0.00%) 
Vascular disorders     
Peripheral embolism  1  1/20 (5.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sildenafil 60 mg Sildenafil 240 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   11/20 (55.00%)   8/12 (66.67%) 
Blood and lymphatic system disorders     
Iron deficiency anaemia  1  1/20 (5.00%)  0/12 (0.00%) 
Cardiac disorders     
Arrhythmia  1  1/20 (5.00%)  1/12 (8.33%) 
Atrial fibrillation  1  0/20 (0.00%)  2/12 (16.67%) 
Tachycardia  1  1/20 (5.00%)  0/12 (0.00%) 
Ear and labyrinth disorders     
Hypoacusis  1  0/20 (0.00%)  1/12 (8.33%) 
Vertigo positional  1  0/20 (0.00%)  1/12 (8.33%) 
Endocrine disorders     
Hypothyroidism  1  1/20 (5.00%)  0/12 (0.00%) 
Eye disorders     
Visual acuity reduced  1  1/20 (5.00%)  0/12 (0.00%) 
Gastrointestinal disorders     
Dyspepsia  1  1/20 (5.00%)  1/12 (8.33%) 
General disorders     
Chest pain  1  2/20 (10.00%)  1/12 (8.33%) 
Fatigue  1  1/20 (5.00%)  0/12 (0.00%) 
Oedema peripheral  1  3/20 (15.00%)  1/12 (8.33%) 
Hepatobiliary disorders     
Hepatomegaly  1  1/20 (5.00%)  0/12 (0.00%) 
Infections and infestations     
Bronchitis  1  0/20 (0.00%)  2/12 (16.67%) 
Influenza  1  1/20 (5.00%)  0/12 (0.00%) 
Pharyngitis  1  1/20 (5.00%)  0/12 (0.00%) 
Tracheitis  1  1/20 (5.00%)  0/12 (0.00%) 
Injury, poisoning and procedural complications     
Joint dislocation  1  0/20 (0.00%)  1/12 (8.33%) 
Investigations     
Platelet count decreased  1  0/20 (0.00%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/20 (0.00%)  1/12 (8.33%) 
Back pain  1  0/20 (0.00%)  1/12 (8.33%) 
Connective tissue disorder  1  0/20 (0.00%)  1/12 (8.33%) 
Mixed connective tissue disease  1  1/20 (5.00%)  0/12 (0.00%) 
Muscular weakness  1  0/20 (0.00%)  1/12 (8.33%) 
Nervous system disorders     
Dizziness  1  1/20 (5.00%)  1/12 (8.33%) 
Headache  1  2/20 (10.00%)  2/12 (16.67%) 
Neuralgia  1  0/20 (0.00%)  1/12 (8.33%) 
Paraesthesia  1  1/20 (5.00%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/20 (0.00%)  1/12 (8.33%) 
Skin and subcutaneous tissue disorders     
Rash generalized  1  1/20 (5.00%)  0/12 (0.00%) 
Vascular disorders     
Hypertension  1  0/20 (0.00%)  1/12 (8.33%) 
Hypotension  1  1/20 (5.00%)  0/12 (0.00%) 
Orthostatic hypotension  1  0/20 (0.00%)  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00946114     History of Changes
Other Study ID Numbers: A1481242
First Submitted: July 22, 2009
First Posted: July 24, 2009
Results First Submitted: March 29, 2010
Results First Posted: April 16, 2010
Last Update Posted: February 15, 2013