Trial | NCT01203371  Report issue

Title

Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS
PHASE III, DOUBLE-BLIND, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF NAFTOPIDIL AND TAMSULOSIN TO TREATMENT THE SYMPTOMS OF LOWER URINARY TRACT IN PATIENTS WITH BENIGN PROSTATE HYPERPLASIA

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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.
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
Study Started
Jan 01
2011
Primary Completion
Sep 01
2011
Study Completion
Jan 01
2012
Last Update
Feb 08
2023

Drug Naftopidil

0,25 mg (2weeks) and 0,50 mg (10 weeks)

Drug Tamsulosin

0,4 mg/day

  • Other names: SECOTEX

Naftopidil Experimental

0,25 mg (2 weeks) and 0,50 mg (10 weeks)

Tamsusolin Active Comparator

0,4 mg/day

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
No Results Posted