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

NCT00693199 | Completed DMC

• 1 other identifier: BMI-AT-02
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms; Hypertension

Keywords

Amlodipine; Terazosin; Lower Urinary Tract Symptoms (LUTS); Essential hypertension; International Prostate Symptom Score (IPSS); Quality Of Life (QOL)

Outcome Measures

Primary Outcomes (1)

• The primary efficacy outcomes were reductions in blood pressure and International Prostate Symptoms Score (IPSS) and sub-scores.

  28th day after treatment

Study Arms (3)

1

EXPERIMENTAL

Drug: amlodipine

2

ACTIVE COMPARATOR

Drug: terazosin

3

EXPERIMENTAL

Drug: amlodipine plus terazosin

Interventions

amlodipine DRUG

amlodipine 5mg once daily for 28 days

1

terazosin DRUG

terazosin 2 mg once daily for 28 days

2

amlodipine plus terazosin DRUG

amlodipine 5 mg plus terazosin 2 mg once daily for 28days

3

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men 50 years or older
• with LUTS \[defined as International Prostate Symptom Score (IPSS) \>= 10\].
• Stage 1 or 2 essential hypertension (SBP \>= 140 mm Hg and \< 180 mm Hg and/or DBP \>= 90 mm Hg and \< 110 mm Hg)

You may not qualify if:

• A history of postural hypotension
• Secondary hypertension
• Prostate cancer
• Prostate surgery or other intervention
• Use of any agents to influence the LUTS symptoms in the last 4 weeks
• Other severe diseases

Sponsors & Collaborators

• Anhui Medical University: lead
• The University of Science and Technology of China: collaborator
• Peking University First Hospital: collaborator

Study Sites (1)

Biomedicine Inistitute of Anhui Medical University

Hefei, Anhui, 230032, China

Location

Related Publications (1)

• Liu H, Liu P, Mao G, Chen G, Wang B, Qin X, Na Y, Liu Z, Wang X, Xu X. Efficacy of combined amlodipine/terazosin therapy in male hypertensive patients with lower urinary tract symptoms: a randomized, double-blind clinical trial. Urology. 2009 Jul;74(1):130-6. doi: 10.1016/j.urology.2008.11.051. Epub 2009 Apr 15.

  PMID: 19371934 DERIVED

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Hypertension; Essential Hypertension

Interventions

Amlodipine; Terazosin

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ping Liu, PhD

  Biomedical Institute of Anhui Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 6, 2008
• Study Start: July 1, 2006
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: August 8, 2008

Record last verified: 2008-06

Locations

CN (1)