Efficacy And Safety Study Of Naftopidil to Patients Treat... | NCT01203371

Studies
Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

NCT01203371

Sponsor

Apsen Farmaceutica S.A.

Status

Withdrawn

Last Update Posted

Feb 8, 2023Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Hyperplasia

Interventions

Naftopidil
Tamsulosin

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BRA10APS001

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2011Actual

Primary Completion Date

Sep 1, 2011Actual

Completion Date

Jan 1, 2012Actual

First Submitted Date

Sep 15, 2010

First Submission Date that Met QC Criteria

Sep 15, 2010

First Posted Date

Sep 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2023

Last Update Posted Date

Feb 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of patients with benign prostatic hyperplasia.

Detailed Description

Inclusion Criteria:

Men ≥ 50 years Signs and symptoms of BPH A total IPSS of ≥ 10 Prostate volume of ≥20 mL (estimated by ultrasonography) PVR > 150mL

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Naftopidil	Experimental	0,25 mg (2 weeks) and 0,50 mg (10 weeks)	Drug: Naftopidil
Tamsusolin	Active Comparator	0,4 mg/day	Drug: Tamsulosin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Naftopidil	Drug	0,25 mg (2weeks) and 0,50 mg (10 weeks)	Naftopidil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
International Prostate Symptom Score		2, 4, 8 and 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Adverse Effect		2, 4, 8 and 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men ≥ 50 years
Signs and symptoms of BPH
IPSS of ≥ 10
Prostate volume of ≥ 20 mL
PVR > 150 mL

Exclusion Criteria:

History of allergy to a AR antagonists
Treatment with antiandrogen drugs
Drugs with anticholinergic activity
Significant history of orthostatic hypotension
Concomitant neurological diseases
Known or suspected neurogenic bladder dysfunction
Carcinoma of the prostate or bladder
Previous surgery for BPH or bladder neck obstruction
History of recurrent UTI
Concomitant active UTI

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital das Clínicas da Faculdade de Medicina da USP		São Paulo		05403-010	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D006965	Hyperplasia
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D011469	Prostatic Diseases
D005832	Genital Diseases, Male

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C064357	naftopidil
D000077409	Tamsulosin

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided