Sildenafil Treatment of COPD associated Pulmonary Hypertension - Sildenafil for PH in COPD

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002237-73-DK

Enrollment

Unknown

Registered

2008-07-09

Start date

2008-07-03

Completion date

Unknown

Last updated

2016-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary hypertension in patients with chronic obstructive lung disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD MedDRA version: 9.1 Level: LLT Classification code 10037400 Term: Pulmonary hypertension

Interventions

Trade Name: Viagra Pharmaceutical Form: Tablet INN or Proposed INN: SILDENAFIL CAS Number: 139755832 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceuti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A diagnosis of COPD-associated pulmonary hypertension by right heart catheterization. Stable COPD Age > 18 Able to understand and read danish Secure anticonception if fertile woman In stable treatment if treated with alfa-blockers Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Reumatological disease compromising walkning ability. Age > 80 years FEV1 30/20 mm Hg or drop in peripheral saturation > 5% in relation to intake of first dose of trial medication. Decreased sight on one eye do to non-arteritis anterior ischaemic opticusneuropathy. Recent stroke or heart attack Certain rare inherited eye diseases (such as retinitis pigmentosa). Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of 3 months treatment with sildenafil (3 x 50 mg) on patients with pulmonary hypertension associated with COPD ;Secondary Objective: To explore whether Pro-NT-brain natriuretic peptide and apelin can serve as biomarkers for pulmonary hypertension in patients with COPD.;Primary end point(s): Six minute walk test Perception of Life quality estimated by St. George Questionnaire Pulmonary pressure estimated by echocardiography Levels of Pro-brain natriuretic peptide and apelin	—

Measure

Time frame

Main Objective: To investigate the effect of 3 months treatment with sildenafil (3 x 50 mg) on patients with pulmonary hypertension associated with COPD ;Secondary Objective: To explore whether Pro-NT-brain natriuretic peptide and apelin can serve as biomarkers for pulmonary hypertension in patients with COPD.;Primary end point(s): Six minute walk test Perception of Life quality estimated by St. George Questionnaire Pulmonary pressure estimated by echocardiography Levels of Pro-brain natriuretic peptide and apelin

—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026