Ignite Creation Date:
2024-05-06 @ 12:43 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01649739
Status:
UNKNOWN
Last Update Posted:
2012-07-25
First Post:
2012-07-22
Brief Title:
Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2012-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with pulmonary arterial hypertension PAH suffer from breathlessness poor quality of life and inability to function despite medical therapy Current consensus states that combination therapy with different classes of PAH-specific therapy is likely to bring additional benefit to PAH patients In this study we plan to study how exercise performance changes when the phosphodiesterase inhibitor vardenafil is added to patients who remain symptomatic from PAH when treated with inhaled iloprost
Following baseline assessment all Patients will start vardenafil 10 mg bid If the drug is tolerated by the patients after a two week period up titration to 20 mg bid will be permitted at the discretion of the investigators
According to treatment protocol up titration will be done carefully and whenever side effects will be reported up titration will be stopped or dosage will be decreased or stopped according to the investigator judgment
Systemic BP will be measured at baseline assessment The patient will attend the clinic for the first dose monitoring 10 mg and after up titration of the study drug to 20 mg
Systemic BP will be measured at baseline assessment The patient will attend the clinic for the first dose monitoring 10 mg and after up titration of the study drug to 20 mg A fall in SBP of30 mmHg will be considered significant or any smaller value at the discretion of the investigator BP will be measured according to the following protocol
Pre-dose Immediately before administration of vardenafil This will be timed approximately one hour prior to the next planned dose of iloprost
Pre-inhalation One hour post vardenafil dose immediately prior to iloprost inhalation
Post-inhalation Immediately following completion of iloprost inhalation and every fifteen minutes for one hour
Prior to discharge Two hours following the iloprost
Later monitoring At all follow-up visits BP will be measured
This is an open-label study to evaluate the safety and efficacy of adding higher doses of vardenafil to inhaled iloprost over 3 months
Following baseline assessment all Patients will start vardenafil 10 mg bid If the drug is tolerated by the patients after a two week period up titration to 20 mg bid will be permitted at the discretion of the investigators
According to treatment protocol up titration will be done carefully and whenever side effects will be reported up titration will be stopped or dosage will be decreased or stopped according to the investigator judgment
Systemic BP will be measured at baseline assessment The patient will attend the clinic for the first dose monitoring 10 mg and after up titration of the study drug to 20 mg
Systemic BP will be measured at baseline assessment The patient will attend the clinic for the first dose monitoring 10 mg and after up titration of the study drug to 20 mg A fall in SBP of30 mmHg will be considered significant or any smaller value at the discretion of the investigator BP will be measured according to the following protocol
Pre-dose Immediately before administration of vardenafil This will be timed approximately one hour prior to the next planned dose of iloprost
Pre-inhalation One hour post vardenafil dose immediately prior to iloprost inhalation
Post-inhalation Immediately following completion of iloprost inhalation and every fifteen minutes for one hour
Prior to discharge Two hours following the iloprost
Later monitoring At all follow-up visits BP will be measured
This is an open-label study to evaluate the safety and efficacy of adding higher doses of vardenafil to inhaled iloprost over 3 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None