Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT01365585
• Date of registration: 01/06/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial Hypertension
• Scientific title: Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial Hypertension
• Date of first enrolment: July 2011
• Target sample size: 227
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01365585
• Study type: Observational

Countries of recruitment

Germany, Ireland

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must be at least 18 years of age at study index;

- Patients must have a diagnosis of PAH. PAH is conventionally defined as a mean
pulmonary arterial pressure (PAP) of > 25 mmHg and a pulmonary capillary wedge
pressure (PCWP) = 15 mmHg and a pulmonary vascular resistance (PVR) = 240 dynes/s/cm-5
at right heart catheterization;

- Patients must have initiated sildenafil for the treatment of their PAH; at dose = 20
mg tid within 5 years prior to study initiation

Exclusion Criteria:

- Patient has known contraindications to sildenafil at study index;

- Patient participated in an investigational study of sildenafil treatment for PAH
during the period beginning 6 months prior to study index



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: sildenafil citrate

Primary Outcome(s)

Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2 [Time Frame: Baseline, Year 2]

Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3 [Time Frame: Baseline, Year 3]

Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1 [Time Frame: Baseline, Year 1]

Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4 [Time Frame: Baseline, Year 4]

Secondary Outcome(s)

Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4 [Time Frame: Baseline, Year 1, 2, 3, 4]

Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4 [Time Frame: Baseline, Year 1, 2, 3, 4]

Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4 [Time Frame: Baseline, Year 1, 2, 3, 4]

Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4 [Time Frame: Baseline, Year 1, 2, 3, 4]

Change From Baseline in New York Heart Association, World Health Organization (NYHA/WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Year 1, 2, 3 and 4 [Time Frame: Baseline, Year 1, 2, 3, 4]

Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4 [Time Frame: Baseline, Year 1, 2, 3, 4]

Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4 [Time Frame: Baseline, Year 1, 2, 3, 4]

Secondary ID(s)

A1481297

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/10/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01365585