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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00693199
Enrollment
360
Registered
2008-06-06
Start date
2006-07-31
Completion date
2006-10-31
Last updated
2008-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

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.

Interventions

DRUGamlodipine

amlodipine 5mg once daily for 28 days

terazosin 2 mg once daily for 28 days

DRUGamlodipine plus terazosin

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

Sponsors

The University of Science and Technology of China
CollaboratorOTHER
Peking University First Hospital
CollaboratorOTHER
Anhui Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The primary efficacy outcomes were reductions in blood pressure and International Prostate Symptoms Score (IPSS) and sub-scores.28th day after treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026