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Single Dose Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension.

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00640315
First received: February 29, 2008
Last updated: March 31, 2013
Last verified: April 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Hypertension, Pulmonary
Pulmonary Disease, Chronic Obstructive
 Drug: Riociguat (BAY63-2521)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Impact of a single dose of BAY63-2521 on pharmacodynamic parameters of the pulmonary system. [ Time Frame: At baseline, on study days 1, 2, and 3. ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: August 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Drug: Riociguat (BAY63-2521)
Two doses, 1 and 2.5 mg BAY63-2521 given as a single dose, will be tested. 10 patients will be included in each dose step.The investigational drug will be given twice per subject, as single dose administration of BAY63-2521 during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with pulmonary hypertension due to COPD, undergoing routine invasive measurement of hemodynamic parameters.
  • Catheters for measurement of hemodynamic parameters (PAP, PCWP, CO, SAP) must be in place independent of the trial.

Exclusion Criteria:

  • Acute exacerbation of COPD,
  • Pre-existing lung disease other than COPD,
  • Acute or severe chronic left heart failure,
  • Severe coronary artery disease,
  • Uncontrolled arterial hypertension;
  • Severe left ventricular hypertrophy,
  • Congenital or acquired valvular or myocardial disease,
  • Systolic blood pressure < 100 mmHg,
  • Heart rate < 55 bpm or >105 bpm,
  • PaO2/FiO2 < 50 mmHg,
  • PaCO2 > 55 mmHg,
  • Severe hepatic insufficiency,
  • Severe renal insufficiency.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640315

Locations
Germany
Heidelberg, Baden-Württemberg, Germany, 69126
Löwenstein, Baden-Württemberg, Germany, 74245
München, Bayern, Germany, 81377
Bad Nauheim, Hessen, Germany, 61231
Gießen, Hessen, Germany, 35392
Dresden, Sachsen, Germany, 01307
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00640315     History of Changes
Other Study ID Numbers: 12915, 2007-003919-31
Study First Received: February 29, 2008
Last Updated: March 31, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Chronic obstructive pulmonary disease
COPD
Pulmonary hypertension

Additional relevant MeSH terms:
Chronic Disease
Hypertension
Hypertension, Pulmonary
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013