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

This study has been completed.

First Received: June 5, 2008 Last Updated: August 7, 2008 History of Changes

Sponsor:	Anhui Medical University
Collaborators:	University of Science and Technology of China Peking University First Hospital
Information provided by:	Anhui Medical University
ClinicalTrials.gov Identifier:	NCT00693199

Purpose

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.

Condition	Intervention
Lower Urinary Tract Symptoms Hypertension	Drug: amlodipine Drug: terazosin Drug: amlodipine plus terazosin

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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Terazosin Terazosin hydrochloride dihydrate Amlodipine Amlodipine besylate

U.S. FDA Resources

Further study details as provided by Anhui Medical University:

Primary Outcome Measures:

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 ]

Enrollment:	360
Study Start Date:	July 2006
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: amlodipine amlodipine 5mg once daily for 28 days
2: Active Comparator	Drug: terazosin terazosin 2 mg once daily for 28 days
3: Experimental	Drug: amlodipine plus terazosin amlodipine 5 mg plus terazosin 2 mg once daily for 28days

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693199

Locations

China, Anhui
Biomedicine Inistitute of Anhui Medical University
Hefei, Anhui, China, 230032

Sponsors and Collaborators

Anhui Medical University

University of Science and Technology of China

Peking University First Hospital

Investigators

Study Director:

Ping Liu, PhD

Biomedical Institute of Anhui Medical University

More Information

No publications provided by Anhui Medical University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	BMI-AT-02
Study First Received:	June 5, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00693199 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Anhui Medical University:

Amlodipine
Terazosin
Lower Urinary Tract Symptoms (LUTS)

Essential hypertension
International Prostate Symptom Score (IPSS)
Quality Of Life (QOL)

Additional relevant MeSH terms:

Neurotransmitter Agents
Vasodilator Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vascular Diseases
Calcium Channel Blockers
Adrenergic alpha-Antagonists
Cardiovascular Agents

Antihypertensive Agents
Pharmacologic Actions
Amlodipine
Terazosine
Membrane Transport Modulators
Therapeutic Uses
Adrenergic Antagonists
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010