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

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ClinicalTrials.gov Identifier: NCT00693199
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : August 8, 2008
Sponsor:
Collaborators:
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

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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00693199


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00693199     History of Changes
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:
Amlodipine
Terazosin
Lower Urinary Tract Symptoms (LUTS)
Essential hypertension
International Prostate Symptom Score (IPSS)
Quality Of Life (QOL)

Additional relevant MeSH terms:
Hypertension
Lower Urinary Tract Symptoms
Vascular Diseases
Cardiovascular Diseases
Urological Manifestations
Signs and Symptoms
Amlodipine
Prazosin
Terazosin
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Urological Agents