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Riociguat in Children With Pulmonary Arterial Hypertension (PAH)

2015-09-30 08:38:23 | BioPortfolio

Summary

This study is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of riociguat at age-, sex- and body-weight-adjusted doses of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID in children from ≥6 to less than 18 years with pulmonary arterial hypertension (PAH) group 1. The study consists of two phases: titration phase up to 8 weeks and a maintenance phase up to 16 weeks.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hypertension, Pulmonary

Intervention

Riociguat (Adempas, BAY63-2521)

Location

Paris
Baden-Württemberg
France
75015

Status

Not yet recruiting

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-09-30T08:38:23-0400

Clinical Trials [2221 Associated Clinical Trials listed on BioPortfolio]

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated w...

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction

The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricula...

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

Provide riociguat therapy to patients with Pulmonary Arterial Hypertension (PAH) originating from the Bayer-sponsored trials 12935 PATENT-2 or 16719 RESPITE who are currently or recently t...

Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEP...

EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated envi...

PubMed Articles [4213 Associated PubMed Articles listed on BioPortfolio]

In this paper we have discussed epidemiology, pathogenesis, and approaches to treatment of chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a unique potentially curable form of pulmonar...

Response to letter from dr Altmayer regarding publication "Sequential treatment with sildenafil and riociguat in patients with persistent or inoperable chronic thromboembolic pulmonary hypertension improves functional class and pulmonary hemodynamics".

Obesity and Pulmonary Hypertension.

Whether the present obesity epidemic will increase the prevalence of pulmonary hypertension over the next decades is unclear. We review the obesity-related mechanisms that may further the development ...

"Activation of Kv7 channels as a novel mechanism for NO/cGMP-induced pulmonary vasodilation".

The nitric oxide-NO/cGMP pathway represents a major physiological signalling controlling pulmonary arterial (PA) tone and drugs activating this pathway are used to treat pulmonary arterial hypertensio...

Pulmonary hypertension in patients with a history of intravenous drug use.

Pulmonary hypertension may be a consequence of intrinsic elevation in pulmonary vasculature resistance or complicate numerous other conditions affecting the cardiac and respiratory systems. In this re...

Medical and Biotech [MESH] Definitions

Hypertrophy and dilation of the RIGHT VENTRICLE of the heart that is caused by PULMONARY HYPERTENSION. This condition is often associated with pulmonary parenchymal or vascular diseases, such as CHRONIC OBSTRUCTIVE PULMONARY DISEASE and PULMONARY EMBOLISM.

Familial or idiopathic hypertension in the PULMONARY CIRCULATION which is not secondary to other disease.

A prostaglandin that is a powerful vasodilator and inhibits platelet aggregation. It is biosynthesized enzymatically from PROSTAGLANDIN ENDOPEROXIDES in human vascular tissue. The sodium salt has been also used to treat primary pulmonary hypertension (HYPERTENSION, PULMONARY).

A multisystemic disorder characterized by a sensorimotor polyneuropathy (POLYNEUROPATHIES), organomegaly, endocrinopathy, monoclonal gammopathy, and pigmentary skin changes. Other clinical features which may be present include EDEMA; CACHEXIA; microangiopathic glomerulopathy; pulmonary hypertension (HYPERTENSION, PULMONARY); cutaneous necrosis; THROMBOCYTOSIS; and POLYCYTHEMIA. This disorder is frequently associated with osteosclerotic myeloma. (From Adams et al., Principles of Neurology, 6th ed, p1335; Rev Med Interne 1997;18(7):553-62)

A malformation of the heart in which the embryonic common PULMONARY VEIN was not incorporated into the LEFT ATRIUM leaving behind a perforated fibromuscular membrane bisecting the left atrium, a three-atrium heart. The opening between the two left atrium sections determines the degree of obstruction to pulmonary venous return, pulmonary venous and pulmonary arterial hypertension.

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