Essential HypertensionPhase 4NCT01131546
Efficacy and Safety of Levamlodipine Besylate Compared to Amlodipine Maleate in Patients With Essential Hypertension
A Phase 4 study testing Levamlodipine besylate and Amlodipine maleate in people with Essential Hypertension, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is designed to compare the safety and efficacy of levamlodipine besylate (2.5mg or 5mg) versus amlodipine maleate (5mg) in patients with mild to moderate essential hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Levamlodipine besylate and Amlodipine maleate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Mar 2011
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients, 18-75 Years
- Patients with mild to moderate essential hypertension (defined as mean BP of 2 visits ≥140mm/90mmHg, and < 180mm/110mmHg)
- Written informed consent
Who cannot join
- Patients with secondary hypertension
- Patients with severe hypertension
- Have to take other drugs that can influence blood pressure during the study
- Allergic to DHP calcium antagonists
- Evidence of congestive heart failure, unstable angina or severe arrhythmia
- Renal or hepatic dysfunction
- Women who are taking contraceptive pills or are likely to be pregnant
- Participate in other clinical trials within 3 months prior to this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Multicenter Trial of Levamlodipine Besylate Versus Amlodipine Maleate in Patients With Essential Hypertension
This study is designed to compare the safety and efficacy of levamlodipine besylate (2.5mg or 5mg) versus amlodipine maleate (5mg) in patients with mild to moderate essential hypertension.
- Conditions
- Essential Hypertension
- Being tested
- Levamlodipine besylate, Amlodipine maleate
- Keywords
- Essential Hypertension, Levamlodipine Besylate, Amlodipine Maleate
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levamlodipine besylateDrug
Once daily, 7AM - 10AM
Amlodipine maleateDrug
Once daily, 7AM - 10AM
| Study group | Role | What they receive |
|---|---|---|
| Levamlodipine besylate (2.5mg) | Experimental | Not described Receives: Drug: Levamlodipine besylate |
| Levamlodipine besylate (5mg) | Experimental | Not described Receives: Drug: Levamlodipine besylate |
| Amlodipine maleate (5mg) | Active comparator | Not described Receives: Drug: Amlodipine maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients)
Measured: Week 8
Secondary outcomes (3)
Change from baseline in systolic blood pressure (SBP)
Measured: Week 8
Change from baseline in diastolic blood pressure (DBP)
Measured: Week 8
Incidence of adverse effects
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startDec 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dayi Hu, MD, Principal investigator, Peking University People's HospitalJinming Yu, Ph.D., Principal investigator, School of Public Health，Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131546
- Sponsor's protocol ID
- SIM-77
- Status last verified
- May 2011
- First submitted
- 25 May 2010
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Trial of Levamlodipine Besylate Versus Amlodipine Maleate in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT01131546
- Acronym / sponsor ID
- SIM-77
- Conditions
- Essential Hypertension
- Keywords
- Essential Hypertension, Levamlodipine Besylate, Amlodipine Maleate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 27 May 2010 (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.
This study is designed to compare the safety and efficacy of levamlodipine besylate (2.5mg or 5mg) versus amlodipine maleate (5mg) in patients with mild to moderate essential hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Levamlodipine besylate (2.5mg) | Experimental | Drug: Levamlodipine besylate |
| Levamlodipine besylate (5mg) | Experimental | Drug: Levamlodipine besylate |
| Amlodipine maleate (5mg) | Active comparator | Drug: Amlodipine maleate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female outpatients, 18-75 Years
- Patients with mild to moderate essential hypertension (defined as mean BP of 2 visits ≥140mm/90mmHg, and < 180mm/110mmHg)
- Written informed consent
Key exclusion criteria (8 listed)
- Patients with secondary hypertension
- Patients with severe hypertension
- Have to take other drugs that can influence blood pressure during the study
- Allergic to DHP calcium antagonists
- Evidence of congestive heart failure, unstable angina or severe arrhythmia
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 |
|---|---|---|
| Levamlodipine besylateOnce daily, 7AM - 10AM | Drug | Levamlodipine besylate (2.5mg), Levamlodipine besylate (5mg) |
| Amlodipine maleateOnce daily, 7AM - 10AM | Drug | Amlodipine maleate (5mg) |
Primary outcome
Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients)
Time frame: Week 8
3 secondary outcomes
Change from baseline in systolic blood pressure (SBP)
Time frame: Week 8
Change from baseline in diastolic blood pressure (DBP)
Time frame: Week 8
Incidence of adverse effects
Time frame: 8 weeks
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 1 Jun 2011.
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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.
Dayi Hu, MD principal investigator
Peking University People's Hospital
Jinming Yu, Ph.D. principal investigator
School of Public Health，Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levamlodipine besylate and Amlodipine maleate in people with Essential Hypertension, run by Jiangsu Simcere Pharmaceutical Co., Ltd. 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 8 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 1 Jun 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients) (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2011.