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

August 7, 2008 updated by: Anhui Medical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Drug: terazosin
terazosin 2 mg once daily for 28 days
EXPERIMENTAL: 1
Drug: amlodipine
amlodipine 5mg once daily for 28 days
EXPERIMENTAL: 3
Drug: amlodipine plus terazosin
amlodipine 5 mg plus terazosin 2 mg once daily for 28days

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Medical University

Collaborators

Peking University First Hospital
The University of Science and Technology of China

Investigators

  • Study Director: Ping Liu, PhD, Biomedical Institute of Anhui Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

October 1, 2006

Study Completion (ACTUAL)

October 1, 2006

Study Registration Dates

First Submitted

June 5, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (ESTIMATE)

June 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 8, 2008

Last Update Submitted That Met QC Criteria

August 7, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMI-AT-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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