JPRN-UMIN000004749
Recruiting
N/A
A study to evaluate the long-term effect of pulmonary hypertension on prognosis, activities of daily living (ADL), cardiac function and pulmonary function in patients with COPD and IPF, respectively, according to baseline severity of pulmonary hypertension and the efficacy and safety of the Tracleer (bosentan hydrate) tablet for prognosis, activities of daily living, cardiac function and pulmonary function in patients with COPD and IIPs, respectively, according to baseline severity of pulmonary hypertension.
Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical School0 sites160 target enrollmentDecember 18, 2010
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Patients with COPD or IPF (WHO functional class II, III or IV), without hypoxia (PaO2 at rest<
- Sponsor
- Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical School
- Enrollment
- 160
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\) Patients already on bosentan or other drugs for pulmonary hypertension 2\) Patients with any disease that can cause right heart overload 3\) Patients with hypoxemia (PaO2\<60mmHg at rest or after 6 minutes walk). 4\) Women who are pregnant or who may be pregnant, and lactating women 5\) Patients with moderate or severe liver disorder 6\) Patients under treatment with ciclosporin, tacrolimus, or glibenclamide 7\) Other patients judged by the investigator to be inappropriate as a subject of this study
Outcomes
Primary Outcomes
Not specified
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