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NCT Number: NCT05546125

a Non-interventional Study of Sildenafil in the Treatment of Pulmonary Arterial Hypertension (PAH) in Adults From China

This observational study will involve analysis of data collected by the National Rare Disease Registry or medical records .The study will describe outcomes only in PAH(Pulmonary arterial hypertension) patients treated with sildenafil; there will be no comparison with another treatment group.

Approximately 100 adults with PAH will be recruited in China hospitals This NIS(non-interventional study) data will be recorded by a physician in the medical records, during the patients' clinical visits, and in the electronic Case Report Forms (CRF).

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Key information

Conditions

Pulmonary Arterial Hypertension (PAH) Hypertension, Pulmonary Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 18 years of age at study index date; (The index date (i.e., Day 1 of the study) is the date when the first sildenafil dose was actually taken, after Revatio® is approved by China authority)
  • A diagnosis of PAH with a mean pulmonary artery pressure of ≥25 mmHg and a mean pulmonary capillary wedge pressure of ≤15 mmHg by right heart catheterization;
  • Initiated sildenafil for the treatment of their PAH based on treatment suggestion from physician ;(Patients who have received sildenafil or are receiving sildenafil are eligible to participate in this study if they met the above inclusion criteria and were ready to start sildenafil (Revatio®) for treatment at screening;)
  • Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion criteria

  • No

Treatment and study plan

as per Physician's prescription

Other

Participants need to take the Revatio as per Physician's prescription

Primary outcomes

  1. Treatment-emergent Adverse Events (TEAEs)

    Time frame: From baseline to week24

    Incidence of TEAEs and the type of TEAEs

  2. Serious adverse events (SAEs)

    Time frame: From baseline to week24

    Incidence of SAE and the type of SAE

Secondary outcomes

  1. 6-MWD (6-minute walk distance)

    Time frame: baseline, week 12, week24

    Change in 6-minute walk distance (6-MWD)

Sponsors and collaborators

Lead sponsor

Pfizer Pharmaceuticals Ltd.

Industry

Registry information

Official study title

A Non-interventional Study to Further Characterize the Safety and Effectiveness of Sildenafil in the Treatment of Pulmonary Arterial Hypertension (PAH) in Adults From China in a Real World Setting

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2022
Registry last updated
Apr 18, 2023

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.

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