A Long-term Extension Study of Riociguat in Patients With... | NCT02759419

Studies
A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension.

NCT02759419

Sponsor

Bayer

Status

Completed

Last Update Posted

Oct 3, 2025Actual

Enrollment

18Actual

Phase

Phase 4

Conditions

Hypertension, Pulmonary

Interventions

Adempas (Riociguat, BAY63-2521)

Countries

France
South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2016-000501-36	EudraCT Number

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 16, 2016Actual

Primary Completion Date

Sep 15, 2025Actual

Completion Date

Sep 15, 2025Actual

First Submitted Date

Apr 29, 2016

First Submission Date that Met QC Criteria

Apr 29, 2016

First Posted Date

May 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2025

Last Update Posted Date

Oct 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To provide riociguat therapy to eligible patients with PAH originating from Bayer-sponsored trials with BAY63-2521/ Riociguat / Adempas® who are currently or recently treated in these trials until lack of patient benefit as assessed by investigator, or commercial availability and reimbursement.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BAY63-2521	Experimental	Single-arm, uncontrolled	Drug: Adempas (Riociguat, BAY63-2521)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adempas (Riociguat, BAY63-2521)	Drug	0.5 to 2.5 mg in 0.5 mg increments (according to individual adapted optimal dose determined in originating study) administered three times daily (tid)

Measure	Description	Time Frame
Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerability		Up to approx. 3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with Pulmonary Arterial Hypertension (PAH) participating or having participated in the Bayer-sponsored studies 12935, 16719 or 18588, who have completed the main study phase and are still being treated with riociguat (either while still being on treatment with the respective study drug or by commercial means with Adempas) and who, in the opinion of the investigator, are expected to continue to have an overall positive benefit/risk from continuing treatment.
Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and 30 days after the last administration of study drug.

Exclusion Criteria:

Ongoing serious adverse event (SAE) from originating study that is assessed as related to riociguat
Pregnant women or breast-feeding women
Any contra-indication to Adempas treatment listed in the BAY63-2521 / Riociguat Investigators's Brochure
Concomitant participation in another clinical study with the study drug
Patients with pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Besançon		25030	France

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases