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

NCT01365585 | Completed Results

• 1 other identifier: A1481297
• Study Type: observational
• Target: 227
• Locations: 2 countries
• Sites: 2

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary arterial hypertension; sildenafil citrate; Revatio

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (7)

• 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

  Baseline, Year 1, 2, 3, 4

• Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4

  Baseline, Year 1, 2, 3, 4

• Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4

  Baseline, Year 1, 2, 3, 4

• Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4

  Baseline, Year 1, 2, 3, 4

• Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4

  Baseline, Year 1, 2, 3, 4

Study Arms (1)

Sildenafil ≥20mg three times daily

Subjects receiving sildenafil ≥20mg three times daily for the treatment of PAH

Drug: sildenafil citrate

Interventions

sildenafil citrate DRUG

Sildenafil citrate, 20mg oral tablets, taken at least three times daily

Sildenafil ≥20mg three times daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (2)

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Mater Misericordiae Hospital

Dublin, 7, Ireland

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 3, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 1, 2021
• Results First Posted: October 31, 2012

Record last verified: 2021-01

Locations

IE (1); DE (1)