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

NCT00640315 | Completed Phase 1 Results

• 2 other identifiers: 129152007-003919-31
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 7

Brief 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).

Conditions

Hypertension, Pulmonary; Pulmonary Disease, Chronic Obstructive

Keywords

Chronic obstructive pulmonary disease; COPD; Pulmonary hypertension

Outcome Measures

Primary Outcomes (8)

• Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Pulmonary Artery Pressure (PAPmean)

  PAPmean was reported during right heart catheterization

  From baseline up to 4 hours after administration

• Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance (PVR)

  PVR was calculated according to the formula PVR = 80\*(PAPmean - pulmonary capillary wedge pressure)/cardiac output

  From baseline up to 4 hours after administration

• Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC) of Riociguat and Metabolite M1 After Single Dose of Riociguat

  Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

• Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat

  Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

• Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose Per kg Body Weight (AUCnorm) of Riociguat and Metabolite M1 After Single Dose of Riociguat

  Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

• Maximum Drug Concentration in Plasma (Cmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat

  Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

• Maximum Drug Concentration in Plasma Divided by Dose (Cmax/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat

  Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

• Maximum Drug Concentration in Plasma Divided by Dose Per kg Body Weight (Cmax,Norm) of Riociguat and Metabolite M1 After Single Dose of Riociguat

  Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose

Secondary Outcomes (48)

• Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Right Atrial Pressure (RAPmean)

  From baseline up to 4 hours after administration

• Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Pulmonary Artery Pressure (PAPsyst)

  From baseline up to 4 hours after administration

• Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Pulmonary Artery Pressure (PAPdiast)

  From baseline up to 4 hours after administration

• Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Capillary Wedge Pressure (PCWP)

  From baseline up to 4 hours after administration

• Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Heart Rate (HR)

  From baseline up to 4 hours after administration

Other Outcomes (5)

• Mean PR Duration (PRmean) - Change From Baseline to Day 3

  Baseline and day 3

• Mean QRS Duration (QRSmean) - Change From Baseline to Day 3

  Baseline and day 3

• Mean QT Duration (QTmean) - Change From Baseline to Day 3

  Baseline and day 3

Study Arms (2)

Riociguat (Adempas, BAY63-2521) 1.0 mg

EXPERIMENTAL

Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.

Drug: Riociguat (Adempas, BAY63-2521) 1.0 mg

Riociguat (Adempas, BAY63-2521) 2.5 mg

EXPERIMENTAL

Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.

Drug: Riociguat (Adempas, BAY63-2521) 2.5 mg

Interventions

Riociguat (Adempas, BAY63-2521) 1.0 mg DRUG

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) 1.0 mg

Riociguat (Adempas, BAY63-2521) 2.5 mg DRUG

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).

Riociguat (Adempas, BAY63-2521) 2.5 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pulmonary hypertension due to COPD, undergoing routine invasive measurement of hemodynamic parameters.
• Catheters for measurement of hemodynamic parameters (PAP \[pulmonary artery pressure\], PCWP \[pulmonary capillary wedge pressure\], CO \[cardiac output\], SBP \[systolic blood pressure\]) must be in place independent of the trial.

You may not qualify if:

• 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 (arterial partial oxygen pressure)/FiO2 (fraction of inspired oxygen) \< 50 mmHg,
• PaCO2 (arterial partial pressure of carbon dioxide) \> 55 mmHg,
• Severe hepatic insufficiency,
• Severe renal insufficiency.

Sponsors & Collaborators

• Bayer: lead

Study Sites (7)

Unknown Facility

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Unknown Facility

Löwenstein, Baden-Wurttemberg, 74245, Germany

Location

Unknown Facility

München, Bavaria, 81377, Germany

Location

Unknown Facility

Bad Nauheim, Hesse, 61231, Germany

Location

Unknown Facility

Giessen, Hesse, 35392, Germany

Location

Unknown Facility

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Unknown Facility

Dresden, Saxony, 01307, Germany

Location

Related Publications (1)

• H.-A. Ghofrani, G. Staehler, E. Gruenig, M. Halank, V. Mitrovic, S. Unger, W. Mueck, R. Frey, J. Behr. The Effect Of The Soluble Guanylate Cyclase Stimulator Riociguat On Hemodynamics In Patients With Pulmonary Hypertension Due To Chronic Obstructive Pulmonary Disease. D96 CLINICAL TRIALS AND OUTCOMES IN PULMONARY HYPERTENSION.

  RESULT

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Disease, Chronic Obstructive

Interventions

riociguat

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 21, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: December 28, 2016
• Results First Posted: February 28, 2014

Record last verified: 2016-11

Locations

DE (7)