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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018436-41 | EudraCT Number |
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Recruitment was only stopped after the statistical power of the study was reached and the study objectives could be met despite the premature discontinuation.
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The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental |
| |
| Arm 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riociguat (BAY63-2521) | Drug | 0.5 mg single oral dose |
| |
| Riociguat (BAY63-2521) |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary artery mean pressure at rest | Peak change from baseline within 6 hours after a single dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event collection | until 30 days after study drug treatment | |
| Plasma concentrations to obtain pharmacokinetic profile of Riociguat | Within 24 hours after study drug treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna | State of Vienna | 1090 | Austria | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24991733 | Derived | Bonderman D, Pretsch I, Steringer-Mascherbauer R, Jansa P, Rosenkranz S, Tufaro C, Bojic A, Lam CSP, Frey R, Ochan Kilama M, Unger S, Roessig L, Lang IM. Acute hemodynamic effects of riociguat in patients with pulmonary hypertension associated with diastolic heart failure (DILATE-1): a randomized, double-blind, placebo-controlled, single-dose study. Chest. 2014 Nov;146(5):1274-1285. doi: 10.1378/chest.14-0106. |
| Label | URL |
|---|---|
| Click here and search for information of Bayer products for Europe | View source |
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| Drug |
1 mg single oral dose |
|
| Riociguat (BAY63-2521) | Drug | 2 mg single oral dose |
|
| Placebo | Drug | single oral dose |
|
| Graz |
| Styria |
| 8020 |
| Austria |
| Graz | Styria | 8036 | Austria |
| Linz | Upper Austria | 4010 | Austria |
| Salzburg | 5020 | Austria |
| Prague | 12808 | Czechia |
| Cologne | North Rhine-Westphalia | 50924 | Germany |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| C542595 | riociguat |
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