CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 23 enrolled
Drug / intervention
Riociguat (Adempas, BAY63-2521) 1.0 mg +1 moredrug
Likely dose
Riociguat (Adempas, BAY63-2521) 1.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00640315
NCT00640315Phase 1Completed
CompareCT.gov

Proof of Concept Study to Investigate Safety, Tolerability, Pharmacokinetics and the Impact on Pulmonary and Systemic Hemodynamics, Gas Exchange and Lung Function Parameters of a Single-dose of BAY63-2521 IR-tablet in Patients With COPD Associated Pulmonary Hypertension in an Non-randomized, Non-blinded Design

Bayer·interventional·Posted Mar 21, 2008·Updated Dec 28, 2016

In Brief

A Phase 1 clinical trial evaluating Riociguat (Adempas, BAY63-2521) 1.0 mg and Riociguat (Adempas, BAY63-2521) 2.5 mg for Hypertension, Pulmonary and Pulmonary Disease, Chronic Obstructive. Completed, enrolled 23 participants across 7 sites.

Detailed Summary

This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of a single oral dose of BAY63-2521 in patients with pulmonary hypertension due to chronic obstructive pulmonary disease (COPD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 21, 2008
Enrollment StartAug 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.3 years ago

Interventions

Riociguat (Adempas, BAY63-2521) 1.0 mgdrug

1.0 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3).

Riociguat (Adempas, BAY63-2521) 2.5 mgdrug

2.5 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3).