An Open Multiple Dose Titration Study In Patients With Pulmonary Hypertension
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hypertension, Pulmonary |
Drug: Riociguat (Adempas, BAY63-2521) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- To investigate the safety, tolerability and feasibility of individual titration of BAY63-2521 according to peripheral systolic blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- To investigate the long term safety and tolerability of BAY63-2521 [ Time Frame: max. 84 months ] [ Designated as safety issue: Yes ]
- 6MWT [ Time Frame: max. 84 months ] [ Designated as safety issue: No ]
- Right heart catheter invasive hemodynamics [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- WHO functional class assessment [ Time Frame: max. 84 months ] [ Designated as safety issue: No ]
- NT-pro BNP [ Time Frame: 75 months ] [ Designated as safety issue: No ]
- Imaging by echo [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Enrollment: | 75 |
| Study Start Date: | January 2007 |
| Study Completion Date: | September 2014 |
| Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Detailed Description:
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00454558
| 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 | |
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
Publications:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00454558 History of Changes |
| Other Study ID Numbers: | 12166 2006-003520-10 |
| Study First Received: | March 28, 2007 |
| Last Updated: | October 14, 2015 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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 |
ClinicalTrials.gov processed this record on September 23, 2016