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

NCT ID: NCT00693199

Last Updated: 2008-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2006-10-31

Brief Summary

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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

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Conditions

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Lower Urinary Tract Symptoms Hypertension

Keywords

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Amlodipine Terazosin Lower Urinary Tract Symptoms (LUTS) Essential hypertension International Prostate Symptom Score (IPSS) Quality Of Life (QOL)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

amlodipine

Intervention Type DRUG

amlodipine 5mg once daily for 28 days

2

Group Type ACTIVE_COMPARATOR

terazosin

Intervention Type DRUG

terazosin 2 mg once daily for 28 days

3

Group Type EXPERIMENTAL

amlodipine plus terazosin

Intervention Type DRUG

amlodipine 5 mg plus terazosin 2 mg once daily for 28days

Interventions

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amlodipine

amlodipine 5mg once daily for 28 days

Intervention Type DRUG

terazosin

terazosin 2 mg once daily for 28 days

Intervention Type DRUG

amlodipine plus terazosin

amlodipine 5 mg plus terazosin 2 mg once daily for 28days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Science and Technology of China

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role collaborator

Anhui Medical University

OTHER

Sponsor Role lead

Principal Investigators

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Ping Liu, PhD

Role: STUDY_DIRECTOR

Biomedical Institute of Anhui Medical University

Locations

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Biomedicine Inistitute of Anhui Medical University

Hefei, Anhui, China

Site Status

Countries

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China

References

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Liu H, Liu P, Mao G, Chen G, Wang B, Qin X, Na Y, Liu Z, Wang X, Xu X. Efficacy of combined amlodipine/terazosin therapy in male hypertensive patients with lower urinary tract symptoms: a randomized, double-blind clinical trial. Urology. 2009 Jul;74(1):130-6. doi: 10.1016/j.urology.2008.11.051. Epub 2009 Apr 15.

Reference Type DERIVED
PMID: 19371934 (View on PubMed)

Other Identifiers

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BMI-AT-02

Identifier Type: -

Identifier Source: org_study_id