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

Not Applicable

Completed

• Conditions: Lower Urinary Tract Symptoms; Hypertension
• Interventions: Drug: amlodipine; Drug: amlodipine plus terazosin; Drug: terazosin

• Registration Number: NCT00693199
• Lead Sponsor: Anhui Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2008-06
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Last Update Submitted: 2008-08-07
• Last Update Posted: 2008-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	amlodipine	-
3	amlodipine plus terazosin	-
2	terazosin	-

Primary Outcome Measures

Name	Time	Method
The primary efficacy outcomes were reductions in blood pressure and International Prostate Symptoms Score (IPSS) and sub-scores.	28th day after treatment

Trial Locations

Locations (1)

Biomedicine Inistitute of Anhui Medical University; 🇨🇳 Hefei, Anhui, China