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

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365585
• Other study ID #: A1481297
• Status: Completed
• Start date: July 2011
• Est. completion date: October 2011

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this observational study is to gain clinical insight on the actual use of sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three times daily for the treatment of PAH.

Description:

The study design proposed is a retrospective chart review going back five years (01 April 2006 estimate) from the time of study initiation (31 March 2011 estimate). Within this five-year period, study index will occur the first time an adult patient begins sildenafil for the treatment of PAH for a period of at least three months. The patient has to be taking sildenafil at doses ≥ 20mg tid for the treatment of PAH.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• sildenafil citrate
Sildenafil citrate, 20mg oral tablets, taken at least three times daily

Locations

Country	Name	City	State
Germany	Medizinische Hochschule Hannover	Hannover
Ireland	Mater Misericordiae Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Germany,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1	6MWD 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.	Baseline, Year 1
Primary	Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2	6MWD 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.	Baseline, Year 2
Primary	Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3	6MWD 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.	Baseline, Year 3
Primary	Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4	6MWD 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.	Baseline, Year 4
Secondary	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	NYHA/WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class, deterioration = increase in functional class, no change = no change in functional class. Number of participants in each functional class was reported.	Baseline, Year 1, 2, 3, 4
Secondary	Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4	RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.	Baseline, Year 1, 2, 3, 4
Secondary	Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4	mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.	Baseline, Year 1, 2, 3, 4
Secondary	Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4	PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm).	Baseline, Year 1, 2, 3, 4
Secondary	Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4	CI: calculated as COsys divided by BSA.	Baseline, Year 1, 2, 3, 4
Secondary	Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4	PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.	Baseline, Year 1, 2, 3, 4
Secondary	Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4	Borg dyspnea scale: 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all;0.5=very very slight (just noticeable); 1=very slight; 2=slight breathlessness; 3=moderate; 4=some what severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum.	Baseline, Year 1, 2, 3, 4