HypertensionNCT00160498
Testing the Efficacy of Different Dosages of Lercanidipine to Reduce Hypertensive Blood Pressure in Normal Weight and Obese Patients
A study testing Lercanidipine in people with Hypertension, run by UCB Pharma.
Trial summary
A double blind study to examine the safety and efficacy of different dosages of lercanidipine in normal weight and obese patients with hypertension Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Lercanidipine
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Aug 2005
- Phase
- Interventional
- 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
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI): 18.0 - 24.9 or 30.0 - 39.9 kg/m2 (extremes included);
- Essential hypertension I or II WHO:
- 140 mmHg ≤ BPs ≤ 179 mmHg and BPd ≤ 109 mmHg at the end of the placebo run-in phase;
Who cannot join
- Secondary hypertension;
- Diabetes mellitus type 1, insulin dependent diabetes mellitus type 2, fasting blood glucose ≥ 160 mg/dl;
- Subjects keeping to a hypocaloric diet (except special diet for diabetics) to reduce body weight;
- History or presence of angioneurotic oedema;
- Subjects developing a hypertensive crisis during wash-out or placebo run-in period;
About this study
Official title: A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Dose-Titration Study to Assess the Efficacy of Lercanidipine 10 mg and 20 mg Once Daily p. o. in Hypertensive Subjects (I or II WHO) With Elevated Body Weight.
A double blind study to examine the safety and efficacy of different dosages of lercanidipine in normal weight and obese patients with hypertension
- Conditions
- Hypertension
- Being tested
- Lercanidipine
- Keywords
- Lercanidipine, calcium antagonist, hypertension, obesity
- Medical subject headings
- Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LercanidipineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline of systolic blood pressure (BPs) after 4 weeks of treatment
Secondary outcomes (1)
Blood pressure, response rate, normalization rate, pulse rate, lipid profile, safety and tolerability. Measures after 4, 8, 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionAug 2005
- Study completionAug 2005
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.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jürgen Scholze, MD, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160498
- Sponsor's protocol ID
- Ler 25-03
- Status last verified
- Mar 2008
- First submitted
- 8 Sep 2005
- Last updated
- 10 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Dose-Titration Study to Assess the Efficacy of Lercanidipine 10 mg and 20 mg Once Daily p. o. in Hypertensive Subjects (I or II WHO) With Elevated Body Weight.
- ClinicalTrials.gov ID
- NCT00160498
- Acronym / sponsor ID
- Ler 25-03
- Conditions
- Hypertension
- Keywords
- Lercanidipine, calcium antagonist, hypertension, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 12 Sep 2005 (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.
A double blind study to examine the safety and efficacy of different dosages of lercanidipine in normal weight and obese patients with hypertension
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI): 18.0 - 24.9 or 30.0 - 39.9 kg/m2 (extremes included);
- Essential hypertension I or II WHO:
- 140 mmHg ≤ BPs ≤ 179 mmHg and BPd ≤ 109 mmHg at the end of the placebo run-in phase;
Key exclusion criteria (5 listed)
- Secondary hypertension;
- Diabetes mellitus type 1, insulin dependent diabetes mellitus type 2, fasting blood glucose ≥ 160 mg/dl;
- Subjects keeping to a hypocaloric diet (except special diet for diabetics) to reduce body weight;
- History or presence of angioneurotic oedema;
- Subjects developing a hypertensive crisis during wash-out or placebo run-in 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 |
|---|---|---|
| Lercanidipine | Drug | – |
Primary outcome
change from baseline of systolic blood pressure (BPs) after 4 weeks of treatment
1 secondary outcome
Blood pressure, response rate, normalization rate, pulse rate, lipid profile, safety and tolerability. Measures after 4, 8, 12 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 10 Mar 2008.
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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.
Jürgen Scholze, MD study director
UCB Pharma
Questions about this trial
What is this clinical trial studying?
A study testing Lercanidipine in people with Hypertension, run by UCB Pharma.
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 5 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 Mar 2008. 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?
change from baseline of systolic blood pressure (BPs) after 4 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 10 Mar 2008.