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

NCT05546125 | Completed

• 1 other identifier: A1481336
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 7

Brief Summary

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).

Conditions

Pulmonary Arterial Hypertension (PAH)

Outcome Measures

Primary Outcomes (2)

• Treatment-emergent Adverse Events (TEAEs)

  Incidence of TEAEs and the type of TEAEs

  From baseline to week24

• Serious adverse events (SAEs)

  Incidence of SAE and the type of SAE

  From baseline to week24

Secondary Outcomes (1)

• 6-MWD (6-minute walk distance)

  baseline, week 12, week24

Interventions

as per Physician's prescription OTHER

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

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

The study population will comprise patients with PAH (including idiopathic pulmonary arterial hypertension, PAH associated with connective tissue disease, and PAH associated with congenital heart disease patients) Patients must meet all of the inclusion criterias to be eligible for inclusion in this study

You may qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Pfizer Pharmaceuticals Ltd.: lead

Study Sites (7)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Guangdong Provincial People's Hospital

Guangdong, Guangzhou, China

Location

The Second Xiangya Hospital Of Central South University

Changsha, Hunan, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

Affiliated Hospital of Jining Medical College

Jining, Shandong, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

Yanan Hospital of Kunming City

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 19, 2022
• Study Start: December 23, 2021
• Primary Completion: February 27, 2023
• Study Completion: February 27, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)