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

Completed

• Conditions: Pulmonary Arterial Hypertension (PAH)

• Registration Number: NCT05546125
• Lead Sponsor: Pfizer Pharmaceuticals Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-23
• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-19
• Primary Completion: 2023-02-27
• Study Completion: 2023-02-27
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serious adverse events (SAEs)	From baseline to week24	Incidence of SAE and the type of SAE
Treatment-emergent Adverse Events (TEAEs)	From baseline to week24	Incidence of TEAEs and the type of TEAEs

Secondary Outcome Measures

Name	Time	Method
6-MWD (6-minute walk distance)	baseline, week 12, week24	Change in 6-minute walk distance (6-MWD)

Trial Locations

Locations (7)

The Second Xiangya Hospital Of Central South University; 🇨🇳 Changsha, Hunan, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangdong, Guangzhou, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

Affiliated Hospital of Jining Medical College; 🇨🇳 Jining, Shandong, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China

Yanan Hospital of Kunming City; 🇨🇳 Kunming, Yunnan, China