Randomised, placebo controlled study of the effect of sildenafil on hypoxia-induced pulmonary hypertension
| ISRCTN | ISRCTN41186152 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41186152 |
| Protocol serial number | PG/02/024 |
| Sponsor | British Heart Foundation (UK) |
| Funder | British Heart Foundation (UK) |
- Submission date
- 08/03/2002
- Registration date
- 08/03/2002
- Last edited
- 06/01/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof MR Wilkins
Scientific
Scientific
Section on Clinical Pharmacology
Imperial College
Hammersmith Hospital
Du Cane Road
London
W12 0NN
United Kingdom
| Phone | +44 (0)20 8383 2049 |
|---|---|
| m.wilkins@ic.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo controlled study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Hypoxia-induced pulmonary hypertension |
| Intervention | 1. Placebo tds for 3 months 2. Sildenafil 25 mg tds for 3 months, or 3. Sildenafil 100 mg tds for 3 months |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | sildenafil |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Key inclusion criteria | 1. Males or females aged 18 years and over 2. Resting pulmonary artery pressure ≥25 mmHg 3. Written informed consent must be obtained by the investigator before the subject is screened for the study |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 31/12/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Section on Clinical Pharmacology
London
W12 0NN
United Kingdom
W12 0NN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/07/2001 | Yes | No |
