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

Primary Purpose

Lower Urinary Tract Symptoms, Hypertension

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
amlodipine
terazosin
amlodipine plus terazosin
Sponsored by
Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms focused on measuring Amlodipine, Terazosin, Lower Urinary Tract Symptoms (LUTS), Essential hypertension, International Prostate Symptom Score (IPSS), Quality Of Life (QOL)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Biomedicine Inistitute of Anhui Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

The primary efficacy outcomes were reductions in blood pressure and International Prostate Symptoms Score (IPSS) and sub-scores.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2008
Last Updated
August 7, 2008
Sponsor
Anhui Medical University
Collaborators
The University of Science and Technology of China, Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00693199
Brief Title
Effect of Amlodipine Monotherapy or Combined With Terazosin on Lower Urinary Tract Symptoms and Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Anhui Medical University
Collaborators
The University of Science and Technology of China, Peking University First Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms, Hypertension
Keywords
Amlodipine, Terazosin, Lower Urinary Tract Symptoms (LUTS), Essential hypertension, International Prostate Symptom Score (IPSS), Quality Of Life (QOL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
amlodipine
Intervention Description
amlodipine 5mg once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
terazosin
Intervention Description
terazosin 2 mg once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
amlodipine plus terazosin
Intervention Description
amlodipine 5 mg plus terazosin 2 mg once daily for 28days
Primary Outcome Measure Information:
Title
The primary efficacy outcomes were reductions in blood pressure and International Prostate Symptoms Score (IPSS) and sub-scores.
Time Frame
28th day after treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Liu, PhD
Organizational Affiliation
Biomedical Institute of Anhui Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Biomedicine Inistitute of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19371934
Citation
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.
Results Reference
derived

Learn more about this trial

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

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