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

This study has been completed.
Sponsor:
Collaborators:
The University of Science and Technology of China
Peking University First Hospital
Information provided by:
Anhui Medical University
ClinicalTrials.gov Identifier:
NCT00693199
First received: June 5, 2008
Last updated: August 7, 2008
Last verified: June 2008
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


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
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
The 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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00693199     History of Changes
Other Study ID Numbers: BMI-AT-02
Study First Received: June 5, 2008
Last Updated: August 7, 2008
Health Authority: China: 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:
Hypertension
Lower Urinary Tract Symptoms
Vascular Diseases
Cardiovascular Diseases
Urological Manifestations
Signs and Symptoms
Amlodipine
Terazosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on October 01, 2014