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Systematic review and meta-analysis
This trial is included in the following systematic reviews and meta-analyses:
Related trials
PACES (Simonneau), 2008 - Sildenafil vs Placebo
EARLY (Galie), 2008 - Bosentan vs Placebo
ARIES (Galie=, 2008 - Ambrisentan vs Placebo
COMBI (Hoeper), 2006 - Inhaled iloprost vs Placebo
Singh, 2006 - Sildenafil vs Placebo
STEP (McLaughlin), 2006 - Inhaled iloprost vs Placebo
STRIDE-2 (Barst), 2006 - Sitaxsentan vs Placebo
BREATH-5 (Galie), 2006 - Bosentan vs Placebo
SERAPH (Wilkins), 2005 - Bosentan vs Sildenafil
SUPER-1 (Galie), 2005 - Sildenafil vs Placebo
STRIDE-1 (Barst), 2004 - Sitaxsentan vs Placebo
BREATH-2 (Humbert), 2004 - Epoprostenol + Bosentan vs Epoprostenol + placebo
Sastry, 2004 - Sildenafil vs Placebo
Barst, 2003 - Beraprost vs Placebo
BREATHE-1 (Rubin), 2002 - Bosentan vs Placebo
Langleben, 2002 - Terbogrel vs Placebo
AIR (Olschewski), 2002 - Iloprost vs Placebo
ALPHABET (Galie), 2002 - Beraprost vs Placebo
Simmoneau, 2002 - Treprostinil vs Placebo
Channick, 2001 - Bosentan vs Placebo
Badesch, 2000 - Epoprostenol vs control
See also:
EARLY (Galie) study, 2008 |
|
| [NCT00091715] |
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 pdf :
Bosentan
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All mecanism for pulmonary hypertension
|
Treatments
| Studied treatment |
Bosentan
|
| Control treatment |
Placebo
|
Patients
| Patients | Patients with WHO FC II pulmonary arterial hypertension |
Method and design
| Randomized effectives | 93 / 92 (studied vs. control) |
| Blinding | double blind |
| Follow-up duration | 24 weeks |
| Primary endpoint | pulmonary vascular resistanceand six-minute walk distance |
Results
n/N
n/N
Hospitalization for any reason
All cause death
| Relative risks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Endpoint | Events (%) | Relative Risk | 95% CI | Endpoint definition in the trial |
Ref | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Studied treat. | Control treat. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Hospitalization for any reason | 1 / 93 (1,1%) | 3 / 92 (3,3%) | 0,33 | [0,03;3,11] | 10044 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| All cause death | 1 / 93 (1,1%) | 1 / 92 (1,1%) | 0,99 | [0,06;15,58] | 10044 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| The primary endpoint (if exists) appears in blod characters | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Reference(s) used for data extraction:
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| Absolute risk reduction | ||||
| Endpoint | Events rate | Absolute risk reduction (ARR) |
||
|---|---|---|---|---|
| Studied treat. | Control treat. | |||
| Hospitalization for any reason | 1,08% | 3,26% | -21,9‰ | |
| All cause death | 1,08% | 1,09% | -0,1‰ | |
Meta-analysis of all similar trials:
All mecanism in pulmonary hypertension for all patients
Reference(s)
| Trials register # | NCT00091715 |
-
Gali� N, Rubin Lj, Hoeper M, Jansa P, Al-Hiti H, Meyer G, Chiossi E, Kusic-Pajic A, Simonneau G.
.
Lancet 2008;371:2093-100
- 10.1016/S0140-6736(08)60919-8
Pubmed
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Hubmed
| Fulltext
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