Lower Urinary Tract SymptomsNCT00693199
Effect of Amlodipine Monotherapy or Combined With Terazosin on Lower Urinary Tract Symptoms and Hypertension
A study testing amlodipine, terazosin and amlodipine plus terazosin in people with Lower Urinary Tract Symptoms and Hypertension, run by Anhui Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Hypertension
- What is being tested?
- amlodipine, terazosin and amlodipine plus terazosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Jul 2006to Oct 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Biomedicine Inistitute of Anhui Medical University
Hefei, Anhui, 230032
About this study
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
- Being tested
- amlodipine, terazosin, amlodipine plus terazosin
- Keywords
- Amlodipine, Terazosin, Lower Urinary Tract Symptoms (LUTS), Essential hypertension, International Prostate Symptom Score (IPSS), Quality Of Life (QOL)
- Medical subject headings
- Lower Urinary Tract Symptoms, Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amlodipineDrug
amlodipine 5mg once daily for 28 days
terazosinDrug
terazosin 2 mg once daily for 28 days
amlodipine plus terazosinDrug
amlodipine 5 mg plus terazosin 2 mg once daily for 28days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: amlodipine |
| 2 | Active comparator | Not described Receives: Drug: terazosin |
| 3 | Experimental | Not described Receives: Drug: amlodipine plus terazosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy outcomes were reductions in blood pressure and International Prostate Symptoms Score (IPSS) and sub-scores.
Measured: 28th day after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJul 2006
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Science and Technology of China, Peking University First Hospital
- Investigators
- Ping Liu, PhD, Study director, Biomedical Institute of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693199
- Sponsor's protocol ID
- BMI-AT-02
- Status last verified
- Jun 2008
- First submitted
- 5 Jun 2008
- Last updated
- 8 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19371934
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Amlodipine Monotherapy or Combined With Terazosin on Lower Urinary Tract Symptoms and Hypertension
- ClinicalTrials.gov ID
- NCT00693199
- Acronym / sponsor ID
- BMI-AT-02
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- The University of Science and Technology of China, Peking University First Hospital
- Study start
- Jul 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: amlodipine |
| 2 | Active comparator | Drug: terazosin |
| 3 | Experimental | Drug: amlodipine plus terazosin |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amlodipineamlodipine 5mg once daily for 28 days | Drug | 1 |
| terazosinterazosin 2 mg once daily for 28 days | Drug | 2 |
| amlodipine plus terazosinamlodipine 5 mg plus terazosin 2 mg once daily for 28days | Drug | 3 |
Primary outcome
The primary efficacy outcomes were reductions in blood pressure and International Prostate Symptoms Score (IPSS) and sub-scores.
Time frame: 28th day after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2008.
- Derived from this study: PubMed 19371934Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping Liu, PhD study director
Biomedical Institute of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amlodipine, terazosin and amlodipine plus terazosin in people with Lower Urinary Tract Symptoms and Hypertension, run by Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy outcomes were reductions in blood pressure and International Prostate Symptoms Score (IPSS) and sub-scores. (time frame: 28th day after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00693199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2008.