Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546735
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia BENIPRO
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Double-blind Double-masked Parallel-group Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BENIPRO
Brief Summary:
The clinical trial to evaluate the fixed-dose combination N0728 with the aim of providing the Brazilian market with an alternative potentially effective safe and convenient therapeutic approach for the treatment of Lower Urinary Tract Symptoms LUTS in men with Benign Prostatic Hyperplasia BPH The fixed-dose combination has synergistic action between drugs from different classes and offers significant potential advantages such as better adherence to treatment The trial will assess the non-inferiority in efficacy and safety of the proposed fixed-dose combination compared to alpha-adrenergic antagonists
Detailed Description:
This is a phase 3 prospective randomized multicenter double-blind double-masked parallel group clinical trial to evaluate the efficacy and safety of the fixed-dose combination FDC of N0728 in the treatment of men with moderate to severe storage symptoms urgency increased urinary frequency urge urinary incontinence and emptying symptoms weak urine stream straining or hesitation in urination sensation of incomplete urination terminal drip associated with benign prostatic hyperplasia BPH
The trial will have a total duration of a maximum of 116 days approximately 16 weeks up to 4 weeks of screening and 12 weeks 4 days of treatment Potential participants will be screened at Visit -1 Participants who are currently using alpha-blockers will be required to undergo a period of 2 weeks of washout thus ensuring the homogeneity of the population at the entry of the trial All participants will have up to 2 weeks to perform the planned laboratory and imaging tests At the randomization visit RV if eligible participants will be randomized in a 11 ratio and begin trial treatment in a double-blind manner During the treatment period participants will return to the study site for two intermediary visits Visit 1 and 2 and after completing 12 weeks of treatment participants are expected to return for the Final Visit FV
The trial will have a total duration of a maximum of 116 days approximately 16 weeks up to 4 weeks of screening and 12 weeks 4 days of treatment Potential participants will be screened at Visit -1 Participants who are currently using alpha-blockers will be required to undergo a period of 2 weeks of washout thus ensuring the homogeneity of the population at the entry of the trial All participants will have up to 2 weeks to perform the planned laboratory and imaging tests At the randomization visit RV if eligible participants will be randomized in a 11 ratio and begin trial treatment in a double-blind manner During the treatment period participants will return to the study site for two intermediary visits Visit 1 and 2 and after completing 12 weeks of treatment participants are expected to return for the Final Visit FV
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