HypertensionNCT02240641
Effect of Caldine® on Renal Function in Balanced Hypertension
An observational study of Hypertension, run by Boehringer Ingelheim.
Trial summary
The study aimed at comparing the evolution of renal function in patients showing a hypertension treated by various therapeutic strategies. Due to the contract research organisation (CRO) decision in September 2000, the database was locked and not accessible for Boehringer Ingelheim France. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- Lacidipine, Diuretics and antihypertensive drugs
- How many people
- 5,417 participants
- Where
- No sites listed yet
- Study dates
- May 1998to Sep 2000
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with hypertension requiring treatment
Who may be able to join
- patients with hypertension requiring treatment
Who cannot join
- none
About this study
Official title: Study on Protective Effect of Caldine® on Renal Function in Patients With a Balanced Hypertension
The study aimed at comparing the evolution of renal function in patients showing a hypertension treated by various therapeutic strategies.
Due to the contract research organisation (CRO) decision in September 2000, the database was locked and not accessible for Boehringer Ingelheim France. Consequently it was decided to stop the study and not proceed to the analysis. Thus, only safety data were processed in the safety database.
- Conditions
- Hypertension
- Being tested
- Lacidipine, Diuretics, antihypertensive drugs, alpha blockers, Angiotensin-Converting Enzyme Inhibitors
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacidipineDrug
Also called Caldine
DiureticsDrug
antihypertensive drugsDrug
alpha blockersDrug
Angiotensin-Converting Enzyme InhibitorsDrug
beta blockersDrug
| Study group | Role | What they receive |
|---|---|---|
| hypertension treatment strategies | Not described Receives: Drug: Lacidipine; Drug: Diuretics; Drug: antihypertensive drugs; Drug: alpha blockers; Drug: Angiotensin-Converting Enzyme Inhibitors; Drug: beta blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startMay 1998
- Primary completionSep 2000
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
- 5,417 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
- NCT02240641
- Sponsor's protocol ID
- 231.334
- Status last verified
- Sep 2014
- First submitted
- 28 Aug 2014
- Last updated
- 16 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Protective Effect of Caldine® on Renal Function in Patients With a Balanced Hypertension
- ClinicalTrials.gov ID
- NCT02240641
- Acronym / sponsor ID
- 231.334
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 5,417 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 1998
- Primary completion
- Sep 2000 (actual)
- First posted
- 16 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.
The study aimed at comparing the evolution of renal function in patients showing a hypertension treated by various therapeutic strategies.
Due to the contract research organisation (CRO) decision in September 2000, the database was locked and not accessible for Boehringer Ingelheim France. Consequently it was decided to stop the study and not proceed to the analysis. Thus, only safety data were processed in the safety database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypertension treatment strategies | – | Drug: Lacidipine, Drug: Diuretics, Drug: antihypertensive drugs, Drug: alpha blockers, Drug: Angiotensin-Converting Enzyme Inhibitors, Drug: beta blockers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with hypertension requiring treatment
Key inclusion criteria (1 listed)
- patients with hypertension requiring treatment
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| LacidipineAlso: Caldine | Drug | hypertension treatment strategies |
| Diuretics | Drug | hypertension treatment strategies |
| antihypertensive drugs | Drug | hypertension treatment strategies |
| alpha blockers | Drug | hypertension treatment strategies |
| Angiotensin-Converting Enzyme Inhibitors | Drug | hypertension treatment strategies |
| beta blockers | Drug | hypertension treatment strategies |
Primary outcome
Number of patients with adverse events
Time frame: up to two years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 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: stopped early, as of the sponsor's last update on 16 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 was stopped early. Results are not available in the source record.
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 adverse events (time frame: up to two years). 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 16 Sep 2014.