A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH. (CHEST-1)

• ClinicalTrials.gov Identifier: NCT00855465
• Recruitment Status: Completed
• First Posted: March 4, 2009
• Results First Posted: March 11, 2014
• Last Update Posted: November 28, 2016
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief Summary:

The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

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

Detailed Description:

Adverse event data will be covered in Adverse events section.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 262 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
• Study Start Date: February 2009
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Riociguat (Adempas, BAY63-2521)_individual dose titration; 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	Drug: Riociguat (Adempas, BAY63-2521); BAY63-2521: 1 mg tid - 2,5 mg tid orally for 16 weeks.
Placebo Comparator: Placebo; Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks	Drug: Placebo; Matching Placebo tid orally for 16 weeks

Outcome Measures

Primary Outcome Measures :

1. 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
   6-minute walking distance (6MWD) is a measure for the objective evaluation of a participant's functional exercise capacity.

Secondary Outcome Measures :

1. Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
   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
2. N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
   N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.
3. World Health Organization (WHO) Functional Class - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
   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 PAH.
4. Percentage of Participants With Clinical Worsening [ Time Frame: At week 16 ]
   The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; rescue endarterectomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH.
5. Borg CR 10 Scale - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
   The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 ("Nothing at all") to 10 ("Extremely strong - Maximal").
6. EQ-5D Utility Score - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
   EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).
7. Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
   The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The LPH total score can range from 0 (best) to 105 (worst).

Other Outcome Measures:

1. All Caused Mortality [ Time Frame: At visit 6 (week 16) ]
   All cause mortality (including cardiovascular mortality) was one component of the composite endpoint "time to clinical worsening".
2. Mean Pulmonary Artery Pressure (PAPmean) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
   Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization.
3. Cardiac Index (CI) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
   The cardiac index (CI) is a calculated hemodynamic parameter. CI is derived from the directly measured parameters cardiac output (CO), divided by the body surface area (BSA). BSA is a calculated parameter, using the subject's height and weight in the DuBois formula. Formula: BSA = (W [kg]*0.425)*(H [cm]*0.725)*0.007184 (m^2)
4. Systolic Blood Pressure (SBP) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
   Systolic systemic arterial blood pressure (SBP) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: 95 - 180 mmHg.
5. Diastolic Blood Pressure (DBP) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
   Diastolic systemic arterial blood pressure (DBP) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: <= 110 mmHg.
6. Heart Rate (HR) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
   Heart rate (HR) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: 50 -105 beats per minute (bpm) at rest.
7. Alanine Aminotransferase (ALT) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
   Alanine Aminotransferase (ALT) is a standard clinical chemistry parameter. Normal range: 0 to 45 U/L.
8. Aspartate Aminotransferase (AST) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
   Aspartate Aminotransferase (AST) is a standard clinical chemistry parameter. Normal range: 0 to 41 U/L.
9. Alkaline Phosphatase (AP) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
   Alkaline phosphatase (AP) is a standard clinical chemistry parameter. Normal range: 40 to 129 U/L (males), 35 to 104 U/L (females)
10. Bilirubin - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Bilirubin is a standard clinical chemistry parameter. Normal range: 0.1 to 1.2 mg/dL
11. Creatinine - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Creatinine is a standard clinical chemistry parameter. Normal range: 0.25 to 1.20 mg/dL (males), 0.46 to 1.00 mg/dL (females)
12. Creatinine Clearance - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Creatinine clearance is a standard clinical chemistry parameter. Normal range: 90 to 140 mL/min (males), 80 to 125 mL/min (females)
13. Creatine Kinase (CK) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Creatine Kinase is a standard clinical chemistry parameter. Normal range: 35 to 232 U/L (males), 26 to 145 U/L (females)
14. Erythrocytes (RBC) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Erythrocytes (red blood cells, RBC) is a standard clinical hematology parameter. Normal range: 4.6 to 5.8*10^12 cells/L (males), 4.1 to 5.2*10^12 cells/L (females)
15. Leukocytes (WBC) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Leukocytes (white blood cells, WBC) is a standard clinical hematology parameter. Normal range: 4.0 to 10.7*10^9 cells/L
16. Lymphocytes - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Total lymphocytes is a standard clinical hematology parameter. Normal range: 1.0 to 4.0*10^9 cells/L
17. Neutrophils - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Neutrophils is a standard clinical hematology parameter. Normal range: 1.6 to 7.4*10^9 cells/L
18. Hemoglobin - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Hemoglobin is a standard clinical hematology parameter. Normal range: 13.5 to 17.5 g/dL (males), 12.0 to 16.0 g/dL (females)
19. Hematocrit - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Hematocrit is a standard clinical hematology parameter. Normal range: 40 to 52% (males), 36 to 46% (females)
20. Potassium - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Potassium is a standard clinical chemistry parameter. Normal range: 3.5 to 5.3 mmol/L
21. Urate - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Urate is a standard clinical chemistry parameter. Normal range: 4.0 to 8.5 mg/dL (males, 16-59 years), 3.4 to 8.7 mg/dL (males, >60 years) 2.5 to 7.5 mg/dL (females)
22. Urea (BUN) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Urea (blood urea nitrogen, BUN) is a standard clinical chemistry parameter. Normal range: 4 to 25 mg/dL
23. Cystatin C - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Cystatin C is a biomarker. Normal range: 0.53 to 1.01 ng/mL
24. Triacylglycerol Lipase - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Triacylglycerol lipase is a standard clinical chemistry parameter. Normal range: 7 to 60 U/L
25. Arterial Partial Pressure of Carbon Dioxide (PaCO2) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Arterial partial pressure of carbon dioxide (PaCO2) is performed as part of the capillary or arterial blood gas analysis. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.
26. Arterial Partial Oxygen Pressure (PaO2) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Arterial partial pressure of oxygen (PaO2) is performed as part of the capillary or arterial blood gas analysis. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.
27. Oxygen Saturation (SaO2) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Oxygen saturation (SaO2) is measured as part of the capillary or arterial blood gas analysis. Normal blood oxygen saturation is considered 95-100 percent. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.
28. Mean PR Duration (PRmean) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    PR duration was evaluated as part of the 12-lead electrocardiogram. electrocardiograms (ECGs) were recorded after the participant had been at rest for 15 minutes in a supine position.
29. Mean QRS Duration (QRSmean) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    QRS duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.
30. Mean QT Duration (QTmean) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    QT duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.
31. Mean QTcB Duration (Bazett's Correction Formula, QTcB) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Bazett-corrected QTcB duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.
32. Mean QTcF Duration (Fridericia's Correction Formula, QTcF) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Fridericia-corrected QTcF duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.
33. Mean RR Duration (RRmean) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    RR duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.
34. Mean Ventricular Rate (VRmean) - Change From Baseline to Week 16 [ Time Frame: Baseline and week 16 ]
    Ventricular rate was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery.

Exclusion Criteria:

• All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension.

Contacts and Locations

Locations

United States, Alabama

Birmingham, Alabama, United States, 35233

United States, California

La Jolla, California, United States, 92093

Sacramento, California, United States, 95817

United States, Colorado

Aurora, Colorado, United States, 80045

United States, Florida

Gainesville, Florida, United States, 32610

Miami, Florida, United States, 33136

Weston, Florida, United States, 33331

United States, Georgia

Atlanta, Georgia, United States, 30342

Decatur, Georgia, United States, 30030

United States, Iowa

Iowa City, Iowa, United States, 52242

United States, Maryland

Baltimore, Maryland, United States, 21201

Baltimore, Maryland, United States, 21205

United States, Massachusetts

Boston, Massachusetts, United States, 02114

Boston, Massachusetts, United States, 02115

Boston, Massachusetts, United States, 02118

United States, Minnesota

Rochester, Minnesota, United States, 55905

United States, New York

Rochester, New York, United States, 14642

United States, Ohio

Cleveland, Ohio, United States, 44195

Columbus, Ohio, United States, 43221

Fairfield, Ohio, United States, 45014

United States, Pennsylvania

Pittsburgh, Pennsylvania, United States, 15212

United States, Rhode Island

Providence, Rhode Island, United States, 02903

United States, Texas

Dallas, Texas, United States, 75390

Houston, Texas, United States, 77030

United States, Utah

Murray, Utah, United States, 84107

United States, Wisconsin

Milwaukee, Wisconsin, United States, 53215

Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1039AAO

Capital Federal, Argentina

Corrientes, Argentina, 3400

Australia, New South Wales

Camperdown, New South Wales, Australia, 2050

Australia, Queensland

Auchenflower, Queensland, Australia, 4066

Chermside, Queensland, Australia, 4032

Australia, Victoria

Prahran, Victoria, Australia, 3181

Austria

Innsbruck, Austria, 6020

Wien, Austria, 1090

Belgium

Bruxelles - Brussel, Belgium, 1070

Leuven, Belgium, 3000

Brazil

Porto Alegre, Rio Grande do Sul, Brazil, 90020 090

São Paulo, Sao Paulo, Brazil, 04024-002

Rio de Janeiro, Brazil, 21941-900

São Paulo, Brazil, 05403-000

Canada, Alberta

Calgary, Alberta, Canada, T1Y 6J4

Canada, Ontario

Hamilton, Ontario, Canada, L8L 2X2

London, Ontario, Canada, N6A 4G5

Ottawa, Ontario, Canada, K1Y 4W7

Toronto, Ontario, Canada, M5G 2N2

Canada, Quebec

Montreal, Quebec, Canada, H3T 1E2

China, Shandong

Qingdao, Shandong, China, 266003

China

Beijing, China, 100020

Beijing, China, 100037

Beijing, China, 100038

Shanghai, China, 200433

Czech Republic

Vseobecna fakultni nemocnice

Praha 2, Czech Republic, 12808

Denmark

Aarhus N, Denmark, 8200

France

Besancon, France, 25030

Brest, France, F-29609

Caen, France, 14033

Hopital Antoine Beclere

Clamart Cedex, France, 92141

GRENOBLE Cedex 09, France, 38043

Lille Cedex, France, 59037

Montpellier, France, 34059

Nice, France, 06200

Pessac, France, 33604

Rouen, France, 76031

Tours, France, 37000

Vandoeuvre Les Nancy, France, F-54500

Germany

Heidelberg, Baden-Württemberg, Germany, 69120

Heidelberg, Baden-Württemberg, Germany, 69126

München, Bayern, Germany, 81377

Regensburg, Bayern, Germany, 93053

Würzburg, Bayern, Germany, 97074

Gießen, Hessen, Germany, 35392

Greifswald, Mecklenburg-Vorpommern, Germany, 17475

Hannover, Niedersachsen, Germany, 30625

Köln, Nordrhein-Westfalen, Germany, 50924

Homburg, Saarland, Germany, 66421

Dresden, Sachsen, Germany, 01307

Leipzig, Sachsen, Germany, 04103

Hamburg, Germany, 20251

Ireland

Dublin, Ireland, DUBLIN 7

Israel

Petah Tikva, Israel, 4941492

Italy

Roma, Lazio, Italy, 00161

Pavia, Lombardia, Italy, 27100

Japan

Nagoya, Aichi, Japan, 467-8602

Seto, Aichi, Japan, 489-8642

Kitakyushu, Fukuoka, Japan, 802-8555

Komatsu, Ishikawa, Japan, 923-8560

Fujisawa, Kanagawa, Japan, 251-0041

Isehara, Kanagawa, Japan, 259-1193

Kawasaki, Kanagawa, Japan, 216-8511

Sendai, Miyagi, Japan, 980-8574

Suwa, Nagano, Japan, 392-8510

Suita, Osaka, Japan, 565-8565

Bunkyo-ku, Tokyo, Japan, 113-8655

Mitaka, Tokyo, Japan, 181-8611

Shinjuku-ku, Tokyo, Japan, 160-8582

Shinjuku-ku, Tokyo, Japan, 162-8655

Chiba, Japan, 260-8677

Fukuoka, Japan, 812-8582

Korea, Republic of

Seoul, Korea, Republic of, 135-710

Seoul, Korea, Republic of, 138-736

Mexico

Guadalajara, Jalisco, Mexico, 44670

Monterrey, Nuevo Leon, Mexico, 64020

Monterrey, Nuevo Leon, Mexico, 64460

Mexico D.F., Mexico, 14080

Querétaro, Mexico, 38000

Netherlands

Amsterdam, Netherlands, 1081 HV

Amsterdam, Netherlands, 1091 AC

Nieuwegein, Netherlands, 3435 CM

Poland

Krakow, Poland, 31-202

Otwock, Poland, 05-400

Wroclaw, Poland, 51-124

Portugal

Coimbra, Portugal, 3000-075

Lisboa, Portugal, 1649-035

Porto, Portugal, 4099-001

Russian Federation

Novosibirsk, Russian Federation, 630055

St. Petersburg, Russian Federation, 197341

Slovakia

Bratislava 37, Slovakia, 833 48

Spain

Barcelona, Spain, 08036

Madrid, Spain, 28041

Switzerland

Zürich, Switzerland, 8091

Taiwan

Kaohsiung, Taiwan, 833

Taipei, Taiwan, 10016

Turkey

Ankara, Turkey

Istanbul, Turkey, 34-390

Izmir, Turkey, 35040

United Kingdom

Cambridge, Cambridgeshire, United Kingdom, CB23 3RE

Glasgow, West Dunbartonshire, United Kingdom, G81 4DY

London, United Kingdom, SW3 6NP

London, United Kingdom, W12 0HS

Newcastle, United Kingdom, NE7 7DN

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

Additional Information:

Click here to find information about studies related to Bayer Healthcare products conducted in Europe 

Publications of Results:

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.

Archer SL. Riociguat for pulmonary hypertension--a glass half full. N Engl J Med. 2013 Jul 25;369(4):386-8. doi: 10.1056/NEJMe1306684. No abstract available.

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.

Wang C, Jing ZC, Huang YG, Zhou DX, Liu ZH, Meier C, Nikkho S, Curram J, Zhang P, He JG. Riociguat for the treatment of pulmonary hypertension: Chinese subgroup analyses and comparison. Heart Asia. 2016 May 17;8(1):74-82. doi: 10.1136/heartasia-2015-010712. eCollection 2016.

Ghofrani HA, Humbert M, Langleben D, Schermuly R, Stasch JP, Wilkins MR, Klinger JR. Riociguat: Mode of Action and Clinical Development in Pulmonary Hypertension. Chest. 2017 Feb;151(2):468-480. doi: 10.1016/j.chest.2016.05.024. Epub 2016 Jun 2.

Kim DY, Kim HJ, Han KH, Han SY, Heo J, Woo HY, Um SH, Kim YH, Kweon YO, Lim HY, Yoon JH, Lee WS, Lee BS, Lee HC, Ryoo BY, Yoon SK. Real-Life Experience of Sorafenib Treatment for Hepatocellular Carcinoma in Korea: From GIDEON Data. Cancer Res Treat. 2016 Oct;48(4):1243-1252. doi: 10.4143/crt.2015.278. Epub 2016 Feb 24.

Kudo M, Ikeda M, Takayama T, Numata K, Izumi N, Furuse J, Okusaka T, Kadoya M, Yamashita S, Ito Y, Kokudo N. Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON. J Gastroenterol. 2016 Dec;51(12):1150-1160. doi: 10.1007/s00535-016-1204-2. Epub 2016 Apr 22.

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

Kim NH, D'Armini AM, Grimminger F, Grunig E, Hoeper MM, Jansa P, Mayer E, Neurohr C, Simonneau G, Torbicki A, Wang C, Fritsch A, Davie N, Ghofrani HA. Haemodynamic effects of riociguat in inoperable/recurrent chronic thromboembolic pulmonary hypertension. Heart. 2017 Apr;103(8):599-606. doi: 10.1136/heartjnl-2016-309621. Epub 2016 Dec 23.

Saleh S, Becker C, Frey R, Muck 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.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00855465
• Other Study ID Numbers: 11348; 2007-000072-16 ( EudraCT Number )
• First Posted: March 4, 2009
• Results First Posted: March 11, 2014
• Last Update Posted: November 28, 2016
• Last Verified: October 2016

Keywords provided by Bayer:

Chronic thromboembolic pulmonary hypertension; PH; soluble Guanylate Cyclase Stimulator; sGC

Additional relevant MeSH terms:

Hypertension, Pulmonary; Hypertension; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Riociguat; Enzyme Activators; Molecular Mechanisms of Pharmacological Action