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

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693199
• Other study ID #: BMI-AT-02
• Status: Completed
• Phase: N/A
• First received: June 5, 2008
• Last updated: August 7, 2008
• Start date: July 2006
• Est. completion date: October 2006

Study information

• Verified date: June 2008
• Source: Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Lower Urinary Tract Symptoms

Intervention

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

Locations

Country	Name	City	State
China	Biomedicine Inistitute of Anhui Medical University	Hefei	Anhui

Sponsors (3)

Lead Sponsor	Collaborator
Anhui Medical University	Peking University First Hospital, The University of Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy outcomes were reductions in blood pressure and International Prostate Symptoms Score (IPSS) and sub-scores.		28th day after treatment	Yes