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

Pulmonary Arterial Hypertension (PAH) Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05546125
• Other study ID #: A1481336
• Status: Completed
• Start date: December 23, 2021
• Est. completion date: February 27, 2023

Study information

• Verified date: April 2023
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 27, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension
• Pulmonary Arterial Hypertension (PAH)

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The Second Xiangya Hospital Of Central South University	Changsha	Hunan
China	Guangdong Provincial People's Hospital	Guangdong	Guangzhou
China	Affiliated Hospital of Jining Medical College	Jining	Shandong
China	Yanan Hospital of Kunming City	Kunming	Yunnan
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer Pharmaceuticals Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent Adverse Events (TEAEs)	Incidence of TEAEs and the type of TEAEs	From baseline to week24
Primary	Serious adverse events (SAEs)	Incidence of SAE and the type of SAE	From baseline to week24
Secondary	6-MWD (6-minute walk distance)	Change in 6-minute walk distance (6-MWD)	baseline, week 12, week24