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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00693199
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : August 8, 2008
The University of Science and Technology of China
Peking University First Hospital
Information provided by:
Anhui Medical University

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.

Condition or disease Intervention/treatment Phase
Lower Urinary Tract Symptoms Hypertension Drug: amlodipine Drug: terazosin Drug: amlodipine plus terazosin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Arm Intervention/treatment
Experimental: 1 Drug: amlodipine
amlodipine 5mg once daily for 28 days

Active Comparator: 2 Drug: terazosin
terazosin 2 mg once daily for 28 days

Experimental: 3 Drug: amlodipine plus terazosin
amlodipine 5 mg plus terazosin 2 mg once daily for 28days

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00693199

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China, Anhui
Biomedicine Inistitute of Anhui Medical University
Hefei, Anhui, China, 230032
Sponsors and Collaborators
Anhui Medical University
The University of Science and Technology of China
Peking University First Hospital
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Study Director: Ping Liu, PhD Biomedical Institute of Anhui Medical University
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00693199    
Other Study ID Numbers: BMI-AT-02
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: August 8, 2008
Last Verified: June 2008
Keywords provided by Anhui Medical University:
Lower Urinary Tract Symptoms (LUTS)
Essential hypertension
International Prostate Symptom Score (IPSS)
Quality Of Life (QOL)
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Vascular Diseases
Cardiovascular Diseases
Urological Manifestations
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Urological Agents