A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
NCT ID: NCT01065454
Last Updated: 2025-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
202 participants
INTERVENTIONAL
2010-04-14
2025-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Riociguat (Adempas, BAY63-2521) up to 2 mg
Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
Riociguat (Adempas, BAY63-2521)
up to 2 mg three times a day (increasing from 0.5 to 1 to 2 mg)
Riociguat (Adempas, BAY63-2521) up to 1 mg
Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
Riociguat (Adempas, BAY63-2521)
up to 1 mg three times a day (increasing from 0.5 to 1 mg)
Riociguat (Adempas, BAY63-2521) fixed 0.5 mg
Participants received riociguat 0.5 mg tid (fixed dose).
Riociguat (Adempas, BAY63-2521)
fixed 0.5 mg three times a day
Placebo
Participants received placebo tid.
Placebo
Placebo three times a day
Interventions
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Riociguat (Adempas, BAY63-2521)
up to 2 mg three times a day (increasing from 0.5 to 1 to 2 mg)
Riociguat (Adempas, BAY63-2521)
up to 1 mg three times a day (increasing from 0.5 to 1 mg)
Riociguat (Adempas, BAY63-2521)
fixed 0.5 mg three times a day
Placebo
Placebo three times a day
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Los Angeles, California, United States
San Diego, California, United States
Torrance, California, United States
Westminster, California, United States
Miami, Florida, United States
Iowa City, Iowa, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Cincinnati, Ohio, United States
Fairfield, Ohio, United States
Falls Church, Virginia, United States
Milwaukee, Wisconsin, United States
Sydney, New South Wales, Australia
Herston, Queensland, Australia
Melbourne, Victoria, Australia
Innsbruck, Tyrol, Austria
Vienna, , Austria
Aalst, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Montreal, Quebec, Canada
Québec, , Canada
Beijing, , China
Shanghai, , China
Shanghai, , China
Brno, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Prague, , Czechia
Aarhus N, , Denmark
Bron, , France
Lille, , France
Nantes, , France
Pessac, , France
Rouen, , France
Toulouse, , France
Heidelberg, Baden-Wurttemberg, Germany
Augsburg, Bavaria, Germany
Greifswald, Mecklenburg-Vorpommern, Germany
Cologne, North Rhine-Westphalia, Germany
Erfurt, Thuringia, Germany
Naples, Campania, Italy
Pavia, Lombardy, Italy
Nagoya, Aichi-ken, Japan
Seto, Aichi-ken, Japan
Ōgaki, Gifu, Japan
Higashiibaraki, Ibaraki, Japan
Tsu, Mie-ken, Japan
Sendai, Miyagi, Japan
Kita-ku, Osaka, Osaka, Japan
Osaka, Osaka, Japan
Suita, Osaka, Japan
Kusatsu, Shiga, Japan
Sunto, Shizuoka, Japan
Arakawa-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Tanabe, Wakayama, Japan
Amsterdam, , Netherlands
Amsterdam, , Netherlands
Nijmegen, , Netherlands
Bydgoszcz, , Poland
Gdansk, , Poland
Warsaw, , Poland
Singapore, , Singapore
Singapore, , Singapore
Singapore, , Singapore
A Coruña, A Coruña, Spain
Majadahonda, Madrid, Spain
Palma, Palma de Mallorca, Spain
Barcelona, , Spain
Madrid, , Spain
Murcia, , Spain
Valencia, , Spain
Geneva, Canton of Geneva, Switzerland
Lugano, Canton Ticino, Switzerland
Zurich, , Switzerland
Cambridge, Cambridgeshire, United Kingdom
London, , United Kingdom
Countries
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References
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Ghio S, Bonderman D, Felix SB, Ghofrani HA, Michelakis ED, Mitrovic V, Oudiz RJ, Frey R, Roessig L, Semigran MJ. Left ventricular systolic dysfunction associated with pulmonary hypertension riociguat trial (LEPHT): rationale and design. Eur J Heart Fail. 2012 Aug;14(8):946-53. doi: 10.1093/eurjhf/hfs071. Epub 2012 Jun 20.
Bonderman D, Ghio S, Felix SB, Ghofrani HA, Michelakis E, Mitrovic V, Oudiz RJ, Boateng F, Scalise AV, Roessig L, Semigran MJ; Left Ventricular Systolic Dysfunction Associated With Pulmonary Hypertension Riociguat Trial (LEPHT) Study Group. Riociguat for patients with pulmonary hypertension caused by systolic left ventricular dysfunction: a phase IIb double-blind, randomized, placebo-controlled, dose-ranging hemodynamic study. Circulation. 2013 Jul 30;128(5):502-11. doi: 10.1161/CIRCULATIONAHA.113.001458. Epub 2013 Jun 17.
Other Identifiers
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2023-507001-34-00
Identifier Type: OTHER
Identifier Source: secondary_id
2009-015878-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14308
Identifier Type: -
Identifier Source: org_study_id
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