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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01365585
First received: June 1, 2011
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Pulmonary Arterial Hypertension
Drug: sildenafil citrate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1 [ Time Frame: Baseline, Year 1 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2 [ Time Frame: Baseline, Year 2 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3 [ Time Frame: Baseline, Year 3 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4 [ Time Frame: Baseline, Year 4 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ] [ Designated as safety issue: No ]
    RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.

  • 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 ] [ Designated as safety issue: No ]
    mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.

  • Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ] [ Designated as safety issue: No ]
    PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm).

  • Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ] [ Designated as safety issue: No ]
    CI: calculated as COsys divided by BSA.

  • Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ] [ Designated as safety issue: No ]
    PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.

  • Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ] [ Designated as safety issue: No ]
    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.


Enrollment: 227
Study Start Date: July 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sildenafil ≥20mg three times daily
Subjects receiving sildenafil ≥20mg three times daily for the treatment of PAH
Drug: sildenafil citrate
Sildenafil citrate, 20mg oral tablets, taken at least three times daily

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365585

Locations
Germany
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Ireland
Mater Misericordiae Hospital
Dublin, Ireland, 7
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01365585     History of Changes
Other Study ID Numbers: A1481297
Study First Received: June 1, 2011
Results First Received: October 5, 2012
Last Updated: January 8, 2013
Health Authority: European Union: European Medicines Agency

Keywords provided by Pfizer:
Pulmonary arterial hypertension
sildenafil citrate
Revatio

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Sildenafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 22, 2014