A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH. (CHEST-1)
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ClinicalTrials.gov Identifier: NCT00855465 |
Recruitment Status :
Completed
First Posted : March 4, 2009
Results First Posted : March 11, 2014
Last Update Posted : November 28, 2016
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Pulmonary Hypertension |
Interventions |
Drug: Riociguat (Adempas, BAY63-2521) Drug: Placebo |
Enrollment | 262 |
Participant Flow
Recruitment Details | Only subjects with symptomatic chronic thromboembolic pulmonary hypertension (CTEPH) could participate in this study. CTEPH was defined either as inoperable or as persisting or recurrent PH after pulmonary endarterectomy. |
Pre-assignment Details | 446 subjects were screened in 89 study centers in 26 countries worldwide. 184 of the 446 screened subjects were not randomized (adverse event [1], death [4], protocol violation [164], withdrawal by subject [15]). 262 of the 446 subjects were randomized. 261 of the 262 randomized subjects received study medication. |
Arm/Group Title | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | Placebo |
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Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks | Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks |
Period Title: Treatment Period | ||
Started | 174 | 88 |
Participants Received Treatment | 173 [1] | 88 |
Completed | 160 | 83 |
Not Completed | 14 | 5 |
Reason Not Completed | ||
Adverse Event | 4 | 2 |
Death | 2 | 2 |
Lack of Efficacy | 2 | 1 |
Non-compliance | 1 | 0 |
Protocol Violation | 2 | 0 |
Withdrawal by Subject | 2 | 0 |
Not treated | 1 | 0 |
[1]
1 subject randomized but not treated
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Period Title: Follow-up Period (FUP) | ||
Started | 17 [1] | 4 [1] |
Completed | 9 | 2 |
Not Completed | 8 | 2 |
Reason Not Completed | ||
Adverse Event | 0 | 1 |
Death | 0 | 1 |
Lost to Follow-up | 3 | 0 |
Withdrawal by Subject | 4 | 0 |
Missing | 1 | 0 |
[1]
Started FUP only if prematurely withdrawn from trt period or if not entering LTE study.
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Baseline Characteristics
Arm/Group Title | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | Placebo | Total | |
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Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks | Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks | Total of all reporting groups | |
Overall Number of Baseline Participants | 173 | 88 | 261 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 173 participants | 88 participants | 261 participants | |
59.3 (13.9) | 59.2 (12.7) | 59.3 (13.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 173 participants | 88 participants | 261 participants | |
Female |
118 68.2%
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54 61.4%
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172 65.9%
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Male |
55 31.8%
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34 38.6%
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89 34.1%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 173 participants | 88 participants | 261 participants |
White | 120 | 65 | 185 | |
Black or African American | 7 | 1 | 8 | |
Asian | 37 | 20 | 57 | |
Mixed | 1 | 0 | 1 | |
Not reported | 8 | 2 | 10 | |
Operability
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 173 participants | 88 participants | 261 participants |
Inoperable CTEPH | 121 | 68 | 189 | |
Postoperative CTEPH | 52 | 20 | 72 | |
[1]
Measure Description: CTEPH defined as inoperable or as persisting/recurrent PH after pulmonary endarterectomy (PEA).
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Body Mass Index
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 173 participants | 88 participants | 261 participants | |
27.13 (5.75) | 27.73 (5.30) | 27.33 (5.60) | ||
6-minute walking distance
[1] Mean (Standard Deviation) Unit of measure: Meters |
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Number Analyzed | 173 participants | 88 participants | 261 participants | |
342.3 (81.9) | 356.0 (74.7) | 346.9 (79.7) | ||
[1]
Measure Description: 6-minute walking distance (6MWD) is a measure for the objective evaluation of a participant's functional exercise capacity.
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WHO (World Health Organization) functional class
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 173 participants | 88 participants | 261 participants |
missing | 0 | 1 | 1 | |
I | 3 | 0 | 3 | |
II | 55 | 25 | 80 | |
III | 107 | 60 | 167 | |
IV | 8 | 2 | 10 | |
[1]
Measure Description: The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of pulmonary arterial hypertension (PAH).
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Pulmonary vascular resistance
[1] Mean (Standard Deviation) Unit of measure: Dyn*s*cm^-5 |
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Number Analyzed | 173 participants | 88 participants | 261 participants | |
790.68 (431.57) | 779.32 (400.94) | 786.68 (420.21) | ||
[1]
Measure Description: The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The embargo can be up to 6 months (equal to the 180 days), moreover if it is necessary the embargo period can be prolonged to expiry of priority year.
Results Point of Contact
Name/Title: | Therapeutic Area Head |
Organization: | Bayer |
EMail: | clinical-trials-contact@bayerhealthcare.com |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT00855465 |
Other Study ID Numbers: |
11348 2007-000072-16 ( EudraCT Number ) |
First Submitted: | December 15, 2008 |
First Posted: | March 4, 2009 |
Results First Submitted: | November 4, 2013 |
Results First Posted: | March 11, 2014 |
Last Update Posted: | November 28, 2016 |