BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension (CHEST-2)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00910429 |
Recruitment Status :
Active, not recruiting
First Posted : May 29, 2009
Last Update Posted : February 5, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Hypertension | Drug: Riociguat (Adempas, BAY63-2521) | Phase 3 |
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 : | November 29, 2019 |
Estimated Study Completion Date : | November 29, 2019 |

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 |
- Safety and tolerability (e.g. adverse event collection) [ Time Frame: 5 years 2 months and 14 days ]
- Change in 6-Minute Walking Distance (6MWD) from baseline [ Time Frame: 5 years 2 months and 14 days ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910429

Study Director: | Bayer Study Director | Bayer |
Additional Information:


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
Last Update Posted: | February 5, 2019 |
Last Verified: | February 2019 |
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 |