BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension (CHEST-2)

Study Description

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Brief Summary:

Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.

Condition or disease	Intervention/treatment	Phase
Pulmonary Hypertension	Drug: Riociguat (Adempas, BAY63-2521)	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	237 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Long-term Extension, Multicentre, Multi-international Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg, 1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Actual Study Start Date :	July 1, 2009
Estimated Primary Completion Date :	December 31, 2018
Estimated Study Completion Date :	December 31, 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Arm 1	Drug: Riociguat (Adempas, BAY63-2521); BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study

Outcome Measures

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Primary Outcome Measures :

1. Safety and tolerability (e.g. adverse event collection) [ Time Frame: 5 years 2 months and 14 days ]

Secondary Outcome Measures :

1. Change in 6-Minute Walking Distance (6MWD) from baseline [ Time Frame: 5 years 2 months and 14 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1

Exclusion Criteria:

• Patients who have an ongoing serious adverse event from CHEST 1 that is assessed as related to BAY63-2521 are not allowed to participate in the extension trial.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 73 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:	Bayer Study Director	Bayer

More Information

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Additional Information:

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Saleh S, Becker C, Frey R, Mück W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.

Simonneau G, D'Armini AM, Ghofrani HA, Grimminger F, Jansa P, Kim NH, Mayer E, Pulido T, Wang C, Colorado P, Fritsch A, Meier C, Nikkho S, Hoeper MM. Predictors of long-term outcomes in patients treated with riociguat for chronic thromboembolic pulmonary hypertension: data from the CHEST-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016 May;4(5):372-80. doi: 10.1016/S2213-2600(16)30022-4. Epub 2016 Apr 8.

Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, Mayer E, Simonneau G, Wilkins MR, Fritsch A, Neuser D, Weimann G, Wang C; CHEST-1 Study Group. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013 Jul 25;369(4):319-29. doi: 10.1056/NEJMoa1209657.

Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT00910429 History of Changes
Other Study ID Numbers:	11349; 2008-003539-19 ( EudraCT Number )
First Posted:	May 29, 2009
Last Update Posted:	March 29, 2018
Last Verified:	March 2018

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Bayer:

Chronic thromboembolic Hypertension; PH; soluble Guanylate Cyclase Stimulator; sGC

Additional relevant MeSH terms:

Hypertension; Hypertension, Pulmonary; Vascular Diseases	Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases