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

Tracking Information

First Received Date ^ICMJE

June 5, 2008

Last Updated Date

August 7, 2008

Start Date ^ICMJE

July 2006

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary efficacy outcomes were reductions in blood pressure and International Prostate Symptoms Score (IPSS) and sub-scores. [ Time Frame: 28th day after treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

The primary efficacy outcomes were changes in LUTS. [ Time Frame: 28th day after treatment ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00693199 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Changes in blood pressure were used as secondary outcomes of efficacy. [ Time Frame: 28th day after treatment ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Lower Urinary Tract Symptoms
Hypertension

Intervention ^ICMJE

Drug: amlodipine
Drug: terazosin
Drug: amlodipine plus terazosin

Study Arms / Comparison Groups

Publications *

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. Epub 2009 Apr 15.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

360

Completion Date

October 2006

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Men 50 years or older
with LUTS [defined as International Prostate Symptom Score (IPSS) >= 10].
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:

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

Gender

Male

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00693199

Responsible Party

Study ID Numbers ^ICMJE

BMI-AT-02

Study Sponsor ^ICMJE

Anhui Medical University

Collaborators ^ICMJE

University of Science and Technology of China
Peking University First Hospital

Investigators ^ICMJE

Study Director:

Ping Liu, PhD

Biomedical Institute of Anhui Medical University

Information Provided By

Anhui Medical University

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP