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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2006

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2
• Experimental: 3

Primary 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
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Anhui Medical University

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00693199

Study ID Number: BMI-AT-02

ClinicalTrials.gov Identifier: NCT00693199

Health Authority: China: State Food and Drug Administration