Clinical trial NCT01365585: Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension
Official title: Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary arterial hypertension
sildenafil citrate
Revatio
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at least 18 years of age diagnosed with pulmonary arterial hypertension (PAH; per Dana Point classification) and treated with sildenafil citrate for their PAH

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1
timeFrame: Baseline, Year 1
measure: Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2
timeFrame: Baseline, Year 2
measure: Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3
timeFrame: Baseline, Year 3
measure: Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4
timeFrame: Baseline, Year 4
Secondary outcomes:
measure: 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
timeFrame: Baseline, Year 1, 2, 3, 4
measure: Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4
timeFrame: Baseline, Year 1, 2, 3, 4
measure: Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4
timeFrame: Baseline, Year 1, 2, 3, 4
measure: Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4
timeFrame: Baseline, Year 1, 2, 3, 4
measure: Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4
timeFrame: Baseline, Year 1, 2, 3, 4
measure: Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4
timeFrame: Baseline, Year 1, 2, 3, 4
measure: Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4
timeFrame: Baseline, Year 1, 2, 3, 4
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Dublin
country: Ireland
facility: Mater Misericordiae Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: