HypertensionNCT02235415
Observation of the Efficacy and Tolerance of Motens® (Lacidipine) in Patients With Essential Hypertension
An observational study of Hypertension, run by Boehringer Ingelheim.
Trial summary
Study of the efficacy and tolerance of Motens® (lacidipine) in patients with essential hypertension. To obtain information on the dosage used in practice and the tolerance at the start of treatment (12 weeks) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Motens® (lacidipine)
- How many people
- 24,526 participants
- Where
- No sites listed yet
- Study dates
- Jun 1998to Sep 1999
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with essential Hypertension recruited by General practicioners, cardiologists and specialists in internal medicine in non-Hospital practice
Who may be able to join
- Non-hospitalised patients of both sexes aged 18 years or more with essential hypertension requiring treatment according to the recommendations of the German League for Hypertension
Who cannot join
- Patients who had the contraindications listed in the product information (the case report file contained a copy of the product information)
About this study
Official title: Observation of the Efficacy and Tolerance of Motens® (Lacidipine) in Patients With Essential Hypertension, Under Normal Conditions Compared With an Open Clinical Trial
Study of the efficacy and tolerance of Motens® (lacidipine) in patients with essential hypertension. To obtain information on the dosage used in practice and the tolerance at the start of treatment (12 weeks)
- Conditions
- Hypertension
- Being tested
- Motens® (lacidipine)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motens® (lacidipine)Drug
| Study group | Role | What they receive |
|---|---|---|
| Motens | Not described Receives: Drug: Motens® (lacidipine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of efficacy by the investigator on a 4-point verbal rating scale based on changes in blood pressure
Measured: Up to 12 weeks after start of drug administration
Assessment of tolerability by investigator on a 4-point verbal rating scale
Measured: Up to 12 weeks after start of drug administration
Number of patients with adverse events
Measured: Up to 12 weeks after start of drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startJun 1998
- Primary completionSep 1999
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24,526 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
- NCT02235415
- Sponsor's protocol ID
- 231.340
- Status last verified
- Sep 2014
- First submitted
- 9 Sep 2014
- Last updated
- 10 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of the Efficacy and Tolerance of Motens® (Lacidipine) in Patients With Essential Hypertension, Under Normal Conditions Compared With an Open Clinical Trial
- ClinicalTrials.gov ID
- NCT02235415
- Acronym / sponsor ID
- 231.340
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24,526 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 1998
- Primary completion
- Sep 1999 (actual)
- First posted
- 10 Sep 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.
Study of the efficacy and tolerance of Motens® (lacidipine) in patients with essential hypertension. To obtain information on the dosage used in practice and the tolerance at the start of treatment (12 weeks)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motens | – | Drug: Motens® (lacidipine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with essential Hypertension recruited by General practicioners, cardiologists and specialists in internal medicine in non-Hospital practice
Key inclusion criteria (1 listed)
- Non-hospitalised patients of both sexes aged 18 years or more with essential hypertension requiring treatment according to the recommendations of the German League for Hypertension
Key exclusion criteria (1 listed)
- Patients who had the contraindications listed in the product information (the case report file contained a copy of the product information)
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 |
|---|---|---|
| Motens® (lacidipine) | Drug | Motens |
Primary outcome
Assessment of efficacy by the investigator on a 4-point verbal rating scale based on changes in blood pressure
Time frame: Up to 12 weeks after start of drug administration
Assessment of tolerability by investigator on a 4-point verbal rating scale
Time frame: Up to 12 weeks after start of drug administration
Number of patients with adverse events
Time frame: Up to 12 weeks after start of drug administration
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 10 Sep 2014.
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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?
An observational study of 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 1 inclusion and 1 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 10 Sep 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.
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?
Assessment of efficacy by the investigator on a 4-point verbal rating scale based on changes in blood pressure (time frame: Up to 12 weeks after start of drug administration). 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 10 Sep 2014; AzTrials last refreshed its copy on 8 Nov 2026.