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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01065454




Registration number
NCT01065454
Ethics application status
Date submitted
8/02/2010
Date registered
9/02/2010

Titles & IDs
Public title
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
Scientific title
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
Secondary ID [1] 0 0
2023-507001-34-00
Secondary ID [2] 0 0
14308
Universal Trial Number (UTN)
Trial acronym
LEPHT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension, Pulmonary 0 0
Ventricular Dysfunction, Left 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Riociguat (Adempas, BAY63-2521)
Treatment: Drugs - Riociguat (Adempas, BAY63-2521)
Treatment: Drugs - Riociguat (Adempas, BAY63-2521)
Treatment: Drugs - Placebo

Experimental: Riociguat (Adempas, BAY63-2521) up to 2 mg - Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).

Experimental: Riociguat (Adempas, BAY63-2521) up to 1 mg - Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).

Experimental: Riociguat (Adempas, BAY63-2521) fixed 0.5 mg - Participants received riociguat 0.5 mg tid (fixed dose).

Placebo comparator: Placebo - Participants received placebo tid.


Treatment: Drugs: Riociguat (Adempas, BAY63-2521)
up to 2 mg three times a day (increasing from 0.5 to 1 to 2 mg)

Treatment: Drugs: Riociguat (Adempas, BAY63-2521)
up to 1 mg three times a day (increasing from 0.5 to 1 mg)

Treatment: Drugs: Riociguat (Adempas, BAY63-2521)
fixed 0.5 mg three times a day

Treatment: Drugs: Placebo
Placebo three times a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16
Timepoint [1] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [1] 0 0
Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16
Timepoint [1] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [2] 0 0
Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16
Timepoint [2] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [3] 0 0
Pulmonary Vascular Resistance Index (PVRi) - Change From Baseline to Week 16
Timepoint [3] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [4] 0 0
Systemic Vascular Resistance (SVR) - Change From Baseline to Week 16
Timepoint [4] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [5] 0 0
Systemic Vascular Resistance Index (SVRi) - Change From Baseline to Week 16
Timepoint [5] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [6] 0 0
Transpulmonary Pressure Gradient (TPG) - Change From Baseline to Week 16
Timepoint [6] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [7] 0 0
Pulmonary Capillary Wedge Pressure (PCWP) - Change From Baseline to Week 16
Timepoint [7] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [8] 0 0
Tricuspid Annular Plane Systolic Excursion (TAPSE) - Change From Baseline to Week 16
Timepoint [8] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [9] 0 0
Systolic Pulmonary Arterial Pressure (PAPsyst) - Change From Baseline to Week 16
Timepoint [9] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [10] 0 0
Left Ventricular Ejection Fraction (LVEF) - Change From Baseline to Week 16
Timepoint [10] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [11] 0 0
Left Ventricular End-systolic Volume (LVESV) - Change From Baseline to Week 16
Timepoint [11] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [12] 0 0
Left Ventricular End-diastolic Volume (LVEDV) - Change From Baseline to Week 16
Timepoint [12] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [13] 0 0
E-wave Deceleration Time - Change From Baseline to Week 16
Timepoint [13] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [14] 0 0
Ratio of Mitral Peak Velocity of Early Filling to Mitral Peak Velocity of Late Filling (E/A) - Change From Baseline to Week 16
Timepoint [14] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [15] 0 0
6-minute Walking Distance (6MWD) - Change From Baseline to Week 16
Timepoint [15] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [16] 0 0
WHO (World Health Organization) Functional Class - Change From Baseline to Week 16
Timepoint [16] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [17] 0 0
Percentage of Participants With Clinical Worsening
Timepoint [17] 0 0
At visit 6 (16 weeks)
Secondary outcome [18] 0 0
Borg CR 10 Scale - Change From Baseline to Week 16
Timepoint [18] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [19] 0 0
EQ-5D Utility Score - Change From Baseline to Week 16
Timepoint [19] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [20] 0 0
Minnesota Living With Heart Failure Questionnaire (MLHF) Score - Change From Baseline to Week 16
Timepoint [20] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [21] 0 0
Cystatin C - Change From Baseline to Week 16
Timepoint [21] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [22] 0 0
N-terminal Pro-brain Natriuretic Peptide (NT-pro BNP) - Change From Baseline to Week 16
Timepoint [22] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [23] 0 0
Troponin T - Change From Baseline to Week 16
Timepoint [23] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [24] 0 0
Asymmetric Dimethylarginine (ADMA) - Change From Baseline to Week 16
Timepoint [24] 0 0
Baseline and visit 6 (16 weeks)
Secondary outcome [25] 0 0
Osteopontin - Change From Baseline to Week 16
Timepoint [25] 0 0
Baseline and visit 6 (16 weeks)

Eligibility
Key inclusion criteria
* Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite optimized heart failure therapy
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Types of pulmonary hypertension other than group 2.1 of Dana Point Classification

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
Accrual to date
Final
202
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- Herston
Recruitment hospital [3] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
United States of America
State/province [10] 0 0
Wisconsin
Country [11] 0 0
Austria
State/province [11] 0 0
Tirol
Country [12] 0 0
Austria
State/province [12] 0 0
Wien
Country [13] 0 0
Belgium
State/province [13] 0 0
Aalst
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussels
Country [15] 0 0
Belgium
State/province [15] 0 0
Gent
Country [16] 0 0
Belgium
State/province [16] 0 0
Leuven
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
China
State/province [20] 0 0
Beijing
Country [21] 0 0
China
State/province [21] 0 0
Shanghai
Country [22] 0 0
Czechia
State/province [22] 0 0
Brno
Country [23] 0 0
Czechia
State/province [23] 0 0
Olomouc
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha 2
Country [25] 0 0
Czechia
State/province [25] 0 0
Praha 4
Country [26] 0 0
Denmark
State/province [26] 0 0
Aarhus N
Country [27] 0 0
France
State/province [27] 0 0
Bron Cedex
Country [28] 0 0
France
State/province [28] 0 0
Lille Cedex
Country [29] 0 0
France
State/province [29] 0 0
Nantes
Country [30] 0 0
France
State/province [30] 0 0
Pessac
Country [31] 0 0
France
State/province [31] 0 0
Rouen
Country [32] 0 0
France
State/province [32] 0 0
TOULOUSE cedex
Country [33] 0 0
Germany
State/province [33] 0 0
Baden-Württemberg
Country [34] 0 0
Germany
State/province [34] 0 0
Bayern
Country [35] 0 0
Germany
State/province [35] 0 0
Mecklenburg-Vorpommern
Country [36] 0 0
Germany
State/province [36] 0 0
Nordrhein-Westfalen
Country [37] 0 0
Germany
State/province [37] 0 0
Thüringen
Country [38] 0 0
Italy
State/province [38] 0 0
Campania
Country [39] 0 0
Italy
State/province [39] 0 0
Lombardia
Country [40] 0 0
Japan
State/province [40] 0 0
Aichi
Country [41] 0 0
Japan
State/province [41] 0 0
Gifu
Country [42] 0 0
Japan
State/province [42] 0 0
Ibaraki
Country [43] 0 0
Japan
State/province [43] 0 0
Mie
Country [44] 0 0
Japan
State/province [44] 0 0
Miyagi
Country [45] 0 0
Japan
State/province [45] 0 0
Osaka
Country [46] 0 0
Japan
State/province [46] 0 0
Shiga
Country [47] 0 0
Japan
State/province [47] 0 0
Shizuoka
Country [48] 0 0
Japan
State/province [48] 0 0
Tokyo
Country [49] 0 0
Japan
State/province [49] 0 0
Wakayama
Country [50] 0 0
Netherlands
State/province [50] 0 0
Amsterdam
Country [51] 0 0
Netherlands
State/province [51] 0 0
Nijmegen
Country [52] 0 0
Poland
State/province [52] 0 0
Bydgoszcz
Country [53] 0 0
Poland
State/province [53] 0 0
Gdansk
Country [54] 0 0
Poland
State/province [54] 0 0
Warszawa
Country [55] 0 0
Singapore
State/province [55] 0 0
Singapore
Country [56] 0 0
Spain
State/province [56] 0 0
A Coruña
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid
Country [58] 0 0
Spain
State/province [58] 0 0
Palma De Mallorca
Country [59] 0 0
Spain
State/province [59] 0 0
Barcelona
Country [60] 0 0
Spain
State/province [60] 0 0
Murcia
Country [61] 0 0
Spain
State/province [61] 0 0
Valencia
Country [62] 0 0
Switzerland
State/province [62] 0 0
Genève
Country [63] 0 0
Switzerland
State/province [63] 0 0
Ticino
Country [64] 0 0
Switzerland
State/province [64] 0 0
Zürich
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Cambridgeshire
Country [66] 0 0
United Kingdom
State/province [66] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT01065454