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

NCT02759419 | Completed Phase 4

• 2 other identifiers: 186942016-000501-36
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 9

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.

Conditions

Hypertension, Pulmonary

Outcome Measures

Primary Outcomes (1)

• Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerability

  Up to approx. 3 years

Study Arms (1)

BAY63-2521

EXPERIMENTAL

Single-arm, uncontrolled

Drug: Adempas (Riociguat, BAY63-2521)

Interventions

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)

BAY63-2521

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (9)

Unknown Facility

Besançon, 25030, France

Location

Unknown Facility

Brest, F-29609, France

Location

Unknown Facility

Le Kremlin-Bicêtre, 94275, France

Location

Unknown Facility

Lille, 59037, France

Location

Unknown Facility

Rouen, 76031, France

Location

Unknown Facility

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Unknown Facility

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Unknown Facility

Seoul, Seoul Teugbyeolsi, 3080, South Korea

Location

Unknown Facility

Seoul, 06351, South Korea

Location

Related Links

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

riociguat

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 3, 2016
• Study Start: June 16, 2016
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-10

Locations

KR (4); FR (5)