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

Sponsor

Bayer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT02759419

Collaborator

(none)

Enrollment

Locations

Arm

114.4

Anticipated Duration (Months)

1.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension, Pulmonary	Drug: Adempas (Riociguat, BAY63-2521)	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial

Actual Study Start Date :

Jun 16, 2016

Anticipated Primary Completion Date :

Dec 28, 2025

Anticipated Study Completion Date :

Dec 28, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BAY63-2521 Single-arm, uncontrolled	Drug: Adempas (Riociguat, BAY63-2521) 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)

Arm

Intervention/Treatment

Experimental: BAY63-2521

Single-arm, uncontrolled

Drug: Adempas (Riociguat, BAY63-2521)

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)

Outcome Measures

Primary Outcome Measures

Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerability [Up to approx. 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Besancon		France	25030
2	Brest		France	F-29609
3	Le Kremlin Bicetre Cedex		France	94275
4	Lille Cedex		France	59037
5	Rouen		France	76031
6	Roma	Lazio	Italy	00161
7	Pavia	Lombardia	Italy	27100
8	Seoul	Seoul Teugbyeolsi	Korea, Republic of	03080
9	Seoul		Korea, Republic of	03722
10	Seoul		Korea, Republic of	05505
11	Seoul		Korea, Republic of	06351
12	Krakow		Poland	31-202
13	Lodz		Poland	91-347
14	Otwock		Poland	05-400
15	Wroclaw		Poland	51-124
16	Bangkok		Thailand	10330

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT02759419

Other Study ID Numbers:

18694
2016-000501-36

First Posted:

May 3, 2016

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Arterial Hypertension

Hypertension, Pulmonary

Hypertension

Riociguat

Study Results

No Results Posted as of Aug 4, 2022