Recruitment Complete

Hypertension, Pulmonary, Ventricular Dysfunction, Left

Bayer Identifier:

14308

ClinicalTrials.gov Identifier:

NCT01065454

EudraCT Number:

2009-015878-35

EU CT Number:

2023-507001-34-00

A study to test the effects of Riociguat in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

Trial purpose

The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

Key Participants Requirements

Sex

Both

Age

18 - 80 Years

Trial summary

Enrollment Goal

202

Trial Dates

April 2010 - August 2025

Phase

Phase 2

Could I Receive a placebo

Yes

Products

Adempas (Riociguat, BAY63-2521)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Withdrawn		Berlin, 13353, Germany
Completed		Heidelberg, 69115, Germany
Completed		Augsburg, 86156, Germany
Withdrawn		Heidelberg, 69126, Germany
Completed		Cambridge, CB23 3RE, United Kingdom
Withdrawn		Sacramento, 95817, United States
Withdrawn		Pittsburgh, 15213, United States
Completed		Rochester, 55905, United States
Completed		Torrance, 90502, United States
Withdrawn		Cleveland, 44106, United States
Withdrawn		Pittsburgh, 15212, United States
Withdrawn		Aurora, 80045, United States
Completed		Greifswald, 17475, Germany
Completed		Köln, 50937, Germany
Withdrawn		Berlin, 12203, Germany
Withdrawn		Gießen, 35392, Germany
Withdrawn		Bad Oeynhausen, 32545, Germany
Completed		Erfurt, 99089, Germany
Completed		Saint Louis, 63110, United States
Completed		San Diego, 92103-8466, United States
Completed		Falls Church, 22042, United States
Completed		Boston, 02114-2696, United States
Completed		Fairfield, 45014, United States
Completed		Miami, 33136, United States
Completed		Nantes, 44035, France
Completed		TOULOUSE cedex, 31059, France
Completed		Rouen, 76031, France
Withdrawn		Lodz, 92-213, Poland
Completed		Sendai, 980-8574, Japan
Completed		Tsu, 514-1101, Japan
Completed		Osaka-shi, 541-8567, Japan
Completed		Kita-ku, Osaka, 530-8480, Japan
Completed		Pavia, 27100, Italy
Active, not recruiting		Pavia, 27100, Italy
Completed		Naples, 80131, Italy
Completed		Barcelona, 08003, Spain
Completed		Valencia, 46026, Spain
Completed		Palma, 7198, Spain
Completed		Quebec, G1V 4G5, Canada
Completed		Lille Cedex, 59037, France
Completed		Bydgoszcz, 85-168, Poland
Withdrawn		Wako, 351-0102, Japan
Completed		Sunto, 411-8611, Japan
Completed		Nagoya, 466-8560, Japan
Completed		Kusatsu, 525-8585, Japan
Completed		Suita, 565-0871, Japan
Withdrawn		Fukuyama, 720-8520, Japan
Withdrawn		Ureshino, 843-0393, Japan
Completed		Madrid, 28041, Spain
Completed		Majadahonda, 28222, Spain
Withdrawn		Sevilla, 41013, Spain
Completed		Edmonton, T6G 2B7, Canada
Completed		Vancouver, V5Z 1M9, Canada
Completed		Brussels, 1070, Belgium
Completed		Montreal, H3T 1E2, Canada
Completed		AMSTERDAM, 1081 HV, Netherlands
Withdrawn		Göteborg, 413 45, Sweden
Completed		Aarhus N, 8200, Denmark
Completed		Sydney, 2010, Australia
Completed		Melbourne, 3004, Australia
Completed		Herston, 4029, Australia
Completed		Innsbruck, 6020, Austria
Withdrawn		Wien, 1160, Austria
Completed		Zürich, 8091, Switzerland
Completed		Lugano, 6900, Switzerland
Completed		Singapore, 308433, Singapore
Completed		Singapore, 119074, Singapore
Completed		Singapore, 169609, Singapore
Completed		LEUVEN, 3000, Belgium
Completed		Wien, 1090, Austria
Withdrawn		Sevilla, 41013, Spain
Completed		Murcia, 30120, Spain
Completed		A Coruna, 15006, Spain
Completed		Geneva, 1205, Switzerland
Completed		Cincinnati, 45219, United States
Completed		BRON CEDEX, 69677, France
Completed		PESSAC, 33604, France
Completed		Beijing, 100020, China
Completed		Shanghai, 200032, China
Withdrawn		Chengdu, 610041, China
Completed		shanghai, 200433, China
Completed		Westminster, 92683, United States
Withdrawn		Bunkyo-ku, 113-8655, Japan
Completed		NIJMEGEN, 6525 GA, Netherlands
Completed		Baltimore, 21201, United States
Completed		Los Angeles, 90073-1003, United States
Completed		Iowa City, 52242, United States
Completed		Seto, 489-8642, Japan
Completed		GENT, 9000, Belgium
Completed		Shinjuku-ku, 162-8666, Japan
Completed		Arakawa-ku, 116-8567, Japan
Withdrawn		Bunkyo-ku, 113-8603, Japan
Completed		Higashiibaraki, 311-3193, Japan
Withdrawn		Milwaukee, 53210, United States
Completed		Milwaukee, 53215, United States
Withdrawn		Osaka, 530-0001, Japan
Completed		Aalst, 9300, Belgium
Completed		London, SW3 6NP, United Kingdom
Completed		Praha 4, 140 21, Czech Republic
Active, not recruiting		Praha 2, 12808, Czech Republic
Completed		Brno, 656 91, Czech Republic
Completed		Olomouc, 77900, Czech Republic
Withdrawn		Brno, 625 00, Czech Republic
Completed		Warszawa, 04-628, Poland
Completed		Ogaki, 503-8502, Japan
Completed		Tanabe, 646-8558, Japan
Withdrawn		Beverly Hills, 90211, United States
Withdrawn		New York, 10021, United States
Completed		Gdansk, 80-214, Poland
Completed		AMSTERDAM, 1091 AC, Netherlands

Primary Outcome

Pulmonary artery mean pressure (PAPmean) at rest - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No

Secondary Outcome

Venous oxygen saturation (SvO2) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Pulmonary vascular resistance (PVR) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Pulmonary vascular resistance index (PVRi) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Systemic vascular resistance (SVR) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Systemic vascular resistance index (SVRi) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Transpulmonary pressure gradient (TPG) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Pulmonary capillary wedge pressure (PCWP) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Tricuspid annular plane systolic excursion (TAPSE) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Systolic pulmonary arterial pressure (PAPsyst) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Left ventricular ejection fraction (LVEF) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Left ventricular end-systolic volume (LVESV) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Left ventricular end-diastolic volume (LVEDV) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
E-wave deceleration time - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Ratio of mitral peak velocity of early filling to mitral peak velocity of late filling (E/A) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
6-minute walking distance (6MWD) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
WHO (World Health Organization) functional class - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Percentage of particpants with clinical worsening
Time Frame:
At visit 6 (16 weeks)
Safety Issue:
No
Borg CR 10 Scale - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
EQ-5D utility score - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Minnesota Living with Heart Failure Questionnaire (MLHF) score - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Cystatin C - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
N-terminal pro-brain natriuretic peptide (NT-pro BNP) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Troponin T - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Asymmetric dimethylarinine (ADMA) - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No
Osteopontin - Change from baseline to week 16
Time Frame:
Baseline and visit 6 (16 weeks)
Safety Issue:
No

Trial design

Randomized, double blind, placebo controlled, parallel group, multi-center study to evaluate the hemodynamic effects of Riociguat (BAY 63-2521) as well as safety and kinetics in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms