HypertensionPhase 3NCT02177331
Lacidipine in Medical Practice in Patients With Mild to Moderate Essential Hypertension
A Phase 3 study testing Lacidipine in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
In order to confirm the proposed metabolic effect of lacidipine these follow-up study was to provide long-term data on its impact on liver function, glucose homoeostasis and lipid metabolism. Additionally, its adverse drug reactions and antihypertensive effects were to be studied. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Lacidipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Jun 1995to Jan 1998
- Phase
- Phase 3
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfillment of entry criteria for the preceding yearly study
- Male or female patients aged between 20 and 85 years
- Known history of mild to moderate essential hypertension requiring drug treatment, WHO grade I to II
- Controlled blood pressure (RR diastolic ≤ 90 mm Hg or 91 - 95 mm Hg and concurrent reduction in blood pressure of at least 10 mm compared to baseline level) during treatment with lacidipine at a dose of 2 - 6 mg once a day
- Final visit of the previous yearly study (Visit 4) completed as scheduled
- Informed consent to participate in the follow-up study
Who cannot join
- Violation of entry/exclusion criteria on enrolment in the preceding yearly study
- Occurrence of the following exclusion criteria in the intervening period:
- Pregnancy, lactation, possibility of conception without the use of a scientifically recognised method of contraception
- Secondary form of hypertension
- Consumptive illness
- Clinically manifest concomitant cardiovascular illness, e.g.: aortic or mitral valve stenosis, hypertrophic obstructive cardiomyopathy or any other condition hindering left ventricular outflow, aortic isthmus stenosis, severe (NYHA Class III or higher) or decompensated heart failure, clinically relevant hypo- or hyperkinetic cardiac arrhythmia
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- Myocardial infarction or cerebrovascular accident within the 6 months prior to the start of the follow-up study
- Hypersensitivity to dihydropyridines
- Concomitant long-term treatment (> 3 weeks) with antihypertensive substances not envisaged in the protocol (exception: short-acting nitrates), sedatives, tricyclic antidepressants
- Suspected alcohol, narcotic or drug abuse
About this study
Official title: Lacidipine in Medical Practice: Incidence of Rare Adverse Drug Reactions During Long-term Treatment. 3rd Follow-up Study - Long-term Use in the 4th and 5th Year Treatment Years
In order to confirm the proposed metabolic effect of lacidipine these follow-up study was to provide long-term data on its impact on liver function, glucose homoeostasis and lipid metabolism. Additionally, its adverse drug reactions and antihypertensive effects were to be studied.
- Conditions
- Hypertension
- Being tested
- Lacidipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacidipineDrug
| Study group | Role | What they receive |
|---|---|---|
| Lacidipine | Experimental | Not described Receives: Drug: Lacidipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with rare adverse drug reactions
Measured: up to 24 months
Change in alkaline phosphatase (AP)
Measured: up to 24 months
Change in serum glutamic - pyruvic transaminase (SGPT)
Measured: up to 24 months
Secondary outcomes (4)
Change in serum glutamic - oxaloacetic transaminase (SGOT)
Measured: up to 24 months
Number of patients with abnormal changes in laboratory parameters
Measured: up to 24 months
Changes in systolic and diastolic blood pressure
Measured: up to 24 months
Changes in gamma glutamyl transferase (gamma-GT)
Measured: up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 1995
- Primary completionJan 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177331
- Sponsor's protocol ID
- 231.215
- Status last verified
- Jul 2014
- First submitted
- 24 Jun 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lacidipine in Medical Practice: Incidence of Rare Adverse Drug Reactions During Long-term Treatment. 3rd Follow-up Study - Long-term Use in the 4th and 5th Year Treatment Years
- ClinicalTrials.gov ID
- NCT02177331
- Acronym / sponsor ID
- 231.215
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 1995
- Primary completion
- Jan 1998 (actual)
- First posted
- 27 Jun 2014 (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.
In order to confirm the proposed metabolic effect of lacidipine these follow-up study was to provide long-term data on its impact on liver function, glucose homoeostasis and lipid metabolism. Additionally, its adverse drug reactions and antihypertensive effects were to be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lacidipine | Experimental | Drug: Lacidipine |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Fulfillment of entry criteria for the preceding yearly study
- Male or female patients aged between 20 and 85 years
- Known history of mild to moderate essential hypertension requiring drug treatment, WHO grade I to II
- Controlled blood pressure (RR diastolic ≤ 90 mm Hg or 91 - 95 mm Hg and concurrent reduction in blood pressure of at least 10 mm compared to baseline level) during treatment with lacidipine at a dose of 2 - 6 mg once a day
- Final visit of the previous yearly study (Visit 4) completed as scheduled
Key exclusion criteria (10 listed)
- Violation of entry/exclusion criteria on enrolment in the preceding yearly study
- Occurrence of the following exclusion criteria in the intervening period:
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 | Drug | Lacidipine |
Primary outcome
Number of patients with rare adverse drug reactions
Time frame: up to 24 months
Change in alkaline phosphatase (AP)
Time frame: up to 24 months
Change in serum glutamic - pyruvic transaminase (SGPT)
Time frame: up to 24 months
4 secondary outcomes
Change in serum glutamic - oxaloacetic transaminase (SGOT)
Time frame: up to 24 months
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 24 months
Changes in systolic and diastolic blood pressure
Time frame: up to 24 months
Changes in gamma glutamyl transferase (gamma-GT)
Time frame: up to 24 month
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 14 Jul 2014.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lacidipine in people with Hypertension, run by Boehringer Ingelheim.
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 6 inclusion and 10 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 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of patients with rare adverse drug reactions (time frame: up to 24 months). The study lists 3 primary outcomes in all. 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 14 Jul 2014.