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An Open Multiple Dose Titration Study In Patients With Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT00454558
Recruitment Status : Completed
First Posted : March 30, 2007
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:

This is a study to demonstrate the feasibility of an individual dose titration scheme based on the systolic blood pressure with a dose range from 1.0 mg TID to 2.5 mg TID. Patients suffering from chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary arterial hypertension (PAH) will be included. After diagnosis by an expert center, patients receive medication three times a day starting with 1.0 mg TID. The first tablets are given in the hospital, then the patients are allowed to go home and take the medication at home. After 2 weeks, patients return to the hospital for an ambulatory visit and the dose may be increased based on the actual condition of the patient (blood pressure and adverse events). Several measurements will be performed to test the efficacy of the drug and whether there are any unwanted reactions to the drug (blood tests, ECG, 6 minute walk test, imaging by Echo, quality of life scores). The dose of the drug will then be increased further until unwanted effects may occur or the blood pressure drops to low. The highest dose tested will be 2.5 mg TID. After 12 weeks the patient is going to stay in the hospital again and a right heart catheter is performed to examine the changes in hemodynamics after 12 weeks of treatment with the drug. If the patients give their consent they can enter a long-term extension trial continuing on BAY63-2521 with the dose reached after 12 weeks. Every 3 months an ambulatory visit at the specialist center will be performed including measurements of safety (blood tests, ECG, clinical assessment) and efficacy (6 minute walk test, Borg dyspnea scale, NT-pro BNP). Blood tests and ECG have been removed begin of 2013 as safety parameter by amendment 7; furthermore Borg dyspnea score and NT-proBNP have been removed as efficacy parameter.

Initially the inclusion of ten patients suffering from chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary arterial hypertension (PAH) was planned. Later on the patient number was amended and 75 patients entered the trial.

Furthermore the trial duration was extended and a long term treatment with BAY63-2521 was offered to the patients. Finally 68 patients moved over to the long term extension period of the trial.


Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Drug: Riociguat (Adempas, BAY63-2521) Phase 2

Detailed Description:
Specification of primary outcome measures for long-term safety and tolerability: Adverse events, blood pressure and heart rate, 12 lead ECG, clinical chemistry and hematology, Troponin I

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Non-randomized, Non-blinded, Noncontrolled Study to Investigate the Impact of Multiple Doses of BAY 63-2521 on Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients With Pulmonary Hypertension in a 12-week 3 Times a Day Individual Dose Titration Scheme
Study Start Date : January 2007
Actual Primary Completion Date : July 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Riociguat

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 Drug: Riociguat (Adempas, BAY63-2521)
Biweekly uptitration of BAY63-2521 (Oral sGC Stimulator) starting from 1.0 mg TID up to 2.5 mg TID in steps of +0.5 mg according to safety and tolerability.


Outcome Measures
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Primary Outcome Measures :
  1. To investigate the safety, tolerability and feasibility of individual titration of BAY63-2521 according to peripheral systolic blood pressure [ Time Frame: 3 months ]
  2. To investigate the long term safety and tolerability of BAY63-2521 [ Time Frame: max. 84 months ]

Secondary Outcome Measures :
  1. 6MWT [ Time Frame: max. 84 months ]
  2. Right heart catheter invasive hemodynamics [ Time Frame: 3 months ]
  3. WHO functional class assessment [ Time Frame: max. 84 months ]
  4. NT-pro BNP [ Time Frame: 75 months ]
  5. Imaging by echo [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with CTEPH or PAH in NYHA class II or III

Exclusion Criteria:

  • Patients with PDE 5 inhibitor or prostacycline pretreatment, relevant pulmonary diseases, relevant cardiac diseases, severe coagulation disorders, moderate to severe hepatic or renal insufficiency, pregnancy, hypotension
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454558


Locations
Germany
Heidelberg, Baden-Württemberg, Germany, 69120
Löwenstein, Baden-Württemberg, Germany, 74245
München, Bayern, Germany, 81377
Regensburg, Bayern, Germany, 93042
Bad Nauheim, Hessen, Germany, 61231
Gießen, Hessen, Germany, 35392
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Hannover, Niedersachsen, Germany, 30625
Köln, Nordrhein-Westfalen, Germany, 50924
Homburg, Saarland, Germany, 66421
Halle, Sachsen-Anhalt, Germany, 06120
Dresden, Sachsen, Germany, 01307
Leipzig, Sachsen, Germany, 04103
Berlin, Germany, 12559
Hamburg, Germany, 20246
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
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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
Click here and search for websynopsis results provided by Bayer.  This link exits the ClinicalTrials.gov site

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00454558     History of Changes
Other Study ID Numbers: 12166
2006-003520-10 ( EudraCT Number )
First Posted: March 30, 2007    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: September 2015

Keywords provided by Bayer:
Pulmonary Arterial Hypertension (PAH)
Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases