a Non-interventional Study of Sildenafil in the Treatment of Pulmonary Arterial Hypertension (PAH) in Adults From China
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Treatment-emergent Adverse Events (TEAEs) [From baseline to week24]
Incidence of TEAEs and the type of TEAEs
- Serious adverse events (SAEs) [From baseline to week24]
Incidence of SAE and the type of SAE
Secondary Outcome Measures
- 6-MWD (6-minute walk distance) [baseline, week 12, week24]
Change in 6-minute walk distance (6-MWD)
Eligibility Criteria
Criteria
Inclusion Criteria:
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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)
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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;
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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;)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China | |
| 2 | Guangdong Provincial People's Hospital | Guangdong | Guangzhou | China | |
| 3 | The Second Xiangya Hospital Of Central South University | Changsha | Hunan | China | |
| 4 | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | China | |
| 5 | Affiliated Hospital of Jining Medical College | Jining | Shandong | China | |
| 6 | Tianjin Medical University General Hospital | Tianjin | Tianjin | China | |
| 7 | Yanan Hospital of Kunming City | Kunming | Yunnan | China |
Sponsors and Collaborators
- Pfizer Pharmaceuticals Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A1481336