Skip to main content
OpenTrials
Completed

NCT Number: NCT01365585

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Hochschule Hannover, Hanover, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sildenafil citrate

Drug

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

Primary outcomes

  1. Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1

    Time frame: Baseline, 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.

  2. Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2

    Time frame: Baseline, 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.

  3. Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3

    Time frame: Baseline, 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.

  4. Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4

    Time frame: Baseline, 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.

Secondary outcomes

  1. 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

    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.

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

    Time frame: Baseline, Year 1, 2, 3, 4

    RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.

  3. 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

    mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.

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

    Time frame: Baseline, Year 1, 2, 3, 4

    PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm).

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

    Time frame: Baseline, Year 1, 2, 3, 4

    CI: calculated as COsys divided by BSA.

  6. Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4

    Time frame: Baseline, Year 1, 2, 3, 4

    PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.

  7. Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4

    Time frame: Baseline, Year 1, 2, 3, 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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 3, 2011
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.