Effect of Amlodipine Monotherapy or Combined With Terazosin on Lower Urinary Tract Symptoms and Hypertension

Anhui Medical University

Status: Completed

Conditions: Hypertension; Lower Urinary Tract Symptoms

Treatments: Drug: amlodipine plus terazosin; Drug: amlodipine; Drug: terazosin

Study type: Interventional

Funder types: Other

Identifiers

NCT00693199

BMI-AT-02

Details and patient eligibility

About

The aim of this study was to investigate the efficacy and safety of low dose amlodipine alone, or combined with low dose terazosin in male patients with both lower urinary tract symptoms and hypertension.

Enrollment: 360 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men 50 years or older
2. with LUTS [defined as International Prostate Symptom Score (IPSS) >= 10].
3. Stage 1 or 2 essential hypertension (SBP >= 140 mm Hg and < 180 mm Hg and/or DBP >= 90 mm Hg and < 110 mm Hg)

Exclusion criteria

1. A history of postural hypotension
2. Secondary hypertension
3. Prostate cancer
4. Prostate surgery or other intervention
5. Use of any agents to influence the LUTS symptoms in the last 4 weeks
6. Other severe diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: amlodipine

2

Active Comparator group

Treatment:

Drug: terazosin

3

Experimental group

Treatment:

Drug: amlodipine plus terazosin