Uncomplicated HypertensionPhase 4NCT00338338
The Efficacy And Safety Of Lacidipine And Amlodipine Once-Daily Treatment In Hypertensive Adult Patients
A Phase 4 study testing Lacidipine 4 or 6 mg (oral) and Amlodipine 5 or 10 mg(oral) in people with Uncomplicated Hypertension and Hypertension, run by GlaxoSmithKline at 1 site in Taiwan.
Trial summary
The sustained reduction in elevated blood pressure and lower incidence of adverse events of Lacidipine may provide additional benefits for hypertension patients than other CCBs (calcium channel blockers). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Uncomplicated Hypertension, Hypertension, Essential
- What is being tested?
- Lacidipine 4 or 6 mg (oral) and Amlodipine 5 or 10 mg(oral)
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Nov 2005to 14 Sep 2007
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent written prior to the recruit into the study
- Male or female subjects
- Patients with diagnosis of essential, uncomplicated hypertension
- After one to two weeks washout period, patients showing, systolic blood pressure equal or lager than 160mmHg or diastolic blood pressure equal or lager than 90mmHg
- Subject could be enrolled in one of the following state:
- Patients previously untreated for hypertension;
- Intolerant or not responding to their current therapy;
- Patients controlled under their previous therapy but who can safely and agree to be switched to the trial therapy could clinically feasible for mono-therapy for hypertension control.
Who cannot join
- Any form of secondary hypertension
- History of malignant hypertension or evidence of accelerated hypertension
- Myocardial infarction within 3 months
- Unstable angina pectoris
- Congestive heart failure
- Atrial fibrillation
Show all 14Show fewer
- Life threatening arrhythmia
- History of cerebrovascular accident
- Clinically relevant renal disease; defines if serum creatinine equal or lager than 1.5 mg/dl
- Liver function abnormal: glutamic-oxalacetic transaminase lager than 2 times of upper limit normal or glutamic-pyruvic transaminase lager than 2 times of upper limit normal
- Existence of any serious systemic disease
- Allergic history to the compounds of both study medication
- Can not comply the study protocol or misunderstand the informed consent form
- Other diseases which treated by calcium channel blockers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Parallel Group, Single-Centre Study to Evaluate the Efficacy and Safety of Lacidipine and Amlodipine Once-daily Treatment in Hypertensive Adult Patients
The sustained reduction in elevated blood pressure and lower incidence of adverse events of Lacidipine may provide additional benefits for hypertension patients than other CCBs (calcium channel blockers). This study is to compare the efficacy and safety of Lacidipine with Amlodipine, the most widely used CCB in Taiwan, in hypertensive patients.
- Conditions
- Uncomplicated Hypertension, Hypertension, Essential
- Being tested
- Lacidipine 4 or 6 mg (oral), Amlodipine 5 or 10 mg(oral)
- Keywords
- essential hypertension, Amlodipine, blood pressure, lacidipine
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacidipine 4 or 6 mg (oral)Drug
Amlodipine 5 or 10 mg(oral)Drug
Also called Lacidipine 4 or 6 mg (oral)
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of of Lacidipine 4 or 6 mg and Amlodipine 5 or 10 mg on blood pressure profiles, in terms of blood pressure, heart rate, and edema after 8 weeks of treatment.
Secondary outcomes (1)
To compare the overall safety profile of Lacidipine and Amlodipine, in terms of percentage and types of adverse events reported after 8 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study start7 Nov 2005
- Primary completion14 Sep 2007
- Study completion14 Sep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated HypertensionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Double blind
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MD, PhD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338338
- Sponsor's protocol ID
- 106357
- Status last verified
- Oct 2017
- First submitted
- 16 Jun 2006
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Group, Single-Centre Study to Evaluate the Efficacy and Safety of Lacidipine and Amlodipine Once-daily Treatment in Hypertensive Adult Patients
- ClinicalTrials.gov ID
- NCT00338338
- Acronym / sponsor ID
- 106357
- Conditions
- Uncomplicated Hypertension, Hypertension, Essential
- Keywords
- essential hypertension, Amlodipine, blood pressure, lacidipine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2005 (actual)
- Primary completion
- 14 Sep 2007 (actual)
- Study completion
- 14 Sep 2007 (actual)
- First posted
- 20 Jun 2006 (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 sustained reduction in elevated blood pressure and lower incidence of adverse events of Lacidipine may provide additional benefits for hypertension patients than other CCBs (calcium channel blockers). This study is to compare the efficacy and safety of Lacidipine with Amlodipine, the most widely used CCB in Taiwan, in hypertensive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed consent written prior to the recruit into the study
- Male or female subjects
- Patients with diagnosis of essential, uncomplicated hypertension
- After one to two weeks washout period, patients showing, systolic blood pressure equal or lager than 160mmHg or diastolic blood pressure equal or lager than 90mmHg
- Patients previously untreated for hypertension;
Key exclusion criteria (14 listed)
- Any form of secondary hypertension
- History of malignant hypertension or evidence of accelerated hypertension
- Myocardial infarction within 3 months
- Unstable angina pectoris
- Congestive heart failure
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 |
|---|---|---|
| Lacidipine 4 or 6 mg (oral) | Drug | – |
| Amlodipine 5 or 10 mg(oral)Also: Lacidipine 4 or 6 mg (oral) | Drug | – |
Primary outcome
To evaluate the efficacy of of Lacidipine 4 or 6 mg and Amlodipine 5 or 10 mg on blood pressure profiles, in terms of blood pressure, heart rate, and edema after 8 weeks of treatment.
1 secondary outcome
To compare the overall safety profile of Lacidipine and Amlodipine, in terms of percentage and types of adverse events reported after 8 weeks of 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 9 Oct 2017.
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.
GSK Clinical Trials, MD, PhD study director
GlaxoSmithKline
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 Lacidipine 4 or 6 mg (oral) and Amlodipine 5 or 10 mg(oral) in people with Uncomplicated Hypertension and Hypertension, run by GlaxoSmithKline at 1 site in Taiwan.
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 8 inclusion and 14 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 9 Oct 2017. 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 Taiwan. 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?
To evaluate the efficacy of of Lacidipine 4 or 6 mg and Amlodipine 5 or 10 mg on blood pressure profiles, in terms of blood pressure, heart rate, and edema after 8 weeks of treatment.. 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 9 Oct 2017.