Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

Apsen Farmaceutica

Status and phase: Withdrawn; Phase 3

Conditions: Hyperplasia

Treatments: Drug: Tamsulosin; Drug: Naftopidil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01203371

APS 001/2010

BRA10APS001

Details and patient eligibility

About

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.

Full 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

Sex: Male

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Naftopidil

Experimental group

Description:

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

Treatment:

Drug: Naftopidil

Tamsusolin

Active Comparator group

Description:

0,4 mg/day

Treatment:

Drug: Tamsulosin