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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-16

Study Completion Date

2025-09-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension, Pulmonary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BAY63-2521

Single-arm, uncontrolled

Group Type EXPERIMENTAL

Adempas (Riociguat, BAY63-2521)

Intervention Type 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)

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No