Essential HypertensionPhase 2FELTNCT01093807
Efficacy and Safety of Lercanidipine and Enalapril in Patients With Essential Hypertension
A Phase 2 study testing Lercanidipine, Enalapril and Lercanidipine + Enalapril in people with Essential Hypertension, run by RECORDATI GROUP at 1 site in France.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of various dosage combinations of lercanidipine (10 and 20 mg)and enalapril (10 and 20 mg) in comparison with their respective components and with placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Lercanidipine, Enalapril and Lercanidipine + Enalapril
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,039 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Apr 2011
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Office Blood Pressure (BP): Sitting diastolic blood pressure (SDBP)100-109 mmHg (inclusive) and sitting systolic blood pressure (SSBP) < 180 mmHg after a 2 week placebo run-in period
- Home Blood Pressure: diastolic blood pressure (DBP)at home ≥ 85 mmHg in the last week of the placebo run-in period
- Normal Electrocardiogram (ECG), first degree Atrioventricular block or other changes not considered clinically significant
Who cannot join
- Secondary or severe hypertension
- History of cerebro- or cardiovascular complications
- Type 1 or Type 2 diabetes on drug treatment
- Severe renal or hepatic insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Parallel Group, Double-blind Trial to Evaluate Different Dose Combinations of Lercanidipine and Enalapril in Comparison With Each Component Administered Alone and With Placebo in Patients With Essential Hypertension
The purpose of this study is to evaluate the efficacy and safety of various dosage combinations of lercanidipine (10 and 20 mg)and enalapril (10 and 20 mg) in comparison with their respective components and with placebo.
- Conditions
- Essential Hypertension
- Being tested
- Placebo, Lercanidipine, Enalapril, Lercanidipine + Enalapril
- Keywords
- Hypertension, Lercanidipine, Calcium antagonist, Enalapril
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
once daily for 10 weeks
LercanidipineDrug
10 mg once daily for 10 weeks
LercanidipineDrug
20 mg once daily for 10 weeks
EnalaprilDrug
10 mg once daily for 10 weeks
EnalaprilDrug
20 mg once daily for 10 weeks
Lercanidipine + EnalaprilDrug
10/10 mg once daily for 10 weeks
Lercanidipine + EnalaprilDrug
10/20 mg once daily for 10 weeks
Lercanidipine + EnalaprilDrug
20/10 mg once daily for 10 weeks
Lercanidipine + EnalaprilDrug
20/20 mg once daily for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Lercanidipine 10 mg | Experimental | Not described Receives: Drug: Lercanidipine |
| Lercanidipine 20 mg | Experimental | Not described Receives: Drug: Lercanidipine |
| Enalapril 10 mg | Experimental | Not described Receives: Drug: Enalapril |
| Enalapril 20 mg | Experimental | Not described Receives: Drug: Enalapril |
| Lercanidipine 10 mg/Enalapril 10 mg | Experimental | Not described Receives: Drug: Lercanidipine + Enalapril |
| Lercanidipine 10mg/Enalapril 20 mg | Experimental | Not described Receives: Drug: Lercanidipine + Enalapril |
| Lercanidipine 20mg/Enalapril 10 mg | Experimental | Not described Receives: Drug: Lercanidipine + Enalapril |
| Lercanidipine 20mg/Enalapril20mg | Experimental | Not described Receives: Drug: Lercanidipine + Enalapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in sitting diastolic blood pressure (SDBP)
Measured: after 10 weeks
Secondary outcomes (2)
Change from baseline in sitting systolic blood pressure (SSBP)
Measured: after 10 weeks
Safety parameters: adverse events, heart rate, laboratory tests physical examination
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,039 participants (actual)
Sponsor and investigators
- Lead sponsor
- RECORDATI GROUP
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Giuseppe Mancia, Prof, Study chair, Clinica Medica Ospedale S. Gerardo Università Milano Bicocca Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093807
- Sponsor's protocol ID
- REC 15/2375-IT-CL 0336
- Acronym
- FELT
- Status last verified
- Apr 2011
- First submitted
- 24 Mar 2010
- Last updated
- 29 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Mancia G, Omboni S, Chazova I, Coca A, Girerd X, Haller H, Parati G, Pauletto P, Pupek-Musialik D, Svyshchenko Y; FELT Study Group. Effects of the lercanidipine-enalapril combination vs. the corresponding monotherapies on home blood pressure in hypertension: evidence from a large database. J Hypertens. 2016 Jan;34(1):139-48. doi: 10.1097/HJH.0000000000000767.
PubMed 26630216
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Parallel Group, Double-blind Trial to Evaluate Different Dose Combinations of Lercanidipine and Enalapril in Comparison With Each Component Administered Alone and With Placebo in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT01093807
- Acronym / sponsor ID
- FELT / REC 15/2375-IT-CL 0336
- Conditions
- Essential Hypertension
- Keywords
- Hypertension, Lercanidipine, Calcium antagonist, Enalapril
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,039 participants (actual)
- Lead sponsor
- RECORDATI GROUPIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 26 Mar 2010 (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 purpose of this study is to evaluate the efficacy and safety of various dosage combinations of lercanidipine (10 and 20 mg)and enalapril (10 and 20 mg) in comparison with their respective components and with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Lercanidipine 10 mg | Experimental | Drug: Lercanidipine |
| Lercanidipine 20 mg | Experimental | Drug: Lercanidipine |
| Enalapril 10 mg | Experimental | Drug: Enalapril |
| Enalapril 20 mg | Experimental | Drug: Enalapril |
| Lercanidipine 10 mg/Enalapril 10 mg | Experimental | Drug: Lercanidipine + Enalapril |
| Lercanidipine 10mg/Enalapril 20 mg | Experimental | Drug: Lercanidipine + Enalapril |
| Lercanidipine 20mg/Enalapril 10 mg | Experimental | Drug: Lercanidipine + Enalapril |
| Lercanidipine 20mg/Enalapril20mg | Experimental | Drug: Lercanidipine + Enalapril |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Office Blood Pressure (BP): Sitting diastolic blood pressure (SDBP)100-109 mmHg (inclusive) and sitting systolic blood pressure (SSBP) < 180 mmHg after a 2 week placebo run-in period
- Home Blood Pressure: diastolic blood pressure (DBP)at home ≥ 85 mmHg in the last week of the placebo run-in period
- Normal Electrocardiogram (ECG), first degree Atrioventricular block or other changes not considered clinically significant
Key exclusion criteria (4 listed)
- Secondary or severe hypertension
- History of cerebro- or cardiovascular complications
- Type 1 or Type 2 diabetes on drug treatment
- Severe renal or hepatic insufficiency
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 |
|---|---|---|
| Placeboonce daily for 10 weeks | Drug | Placebo |
| Lercanidipine10 mg once daily for 10 weeks | Drug | Lercanidipine 10 mg |
| Lercanidipine20 mg once daily for 10 weeks | Drug | Lercanidipine 20 mg |
| Enalapril10 mg once daily for 10 weeks | Drug | Enalapril 10 mg |
| Enalapril20 mg once daily for 10 weeks | Drug | Enalapril 20 mg |
| Lercanidipine + Enalapril10/10 mg once daily for 10 weeks | Drug | Lercanidipine 10 mg/Enalapril 10 mg |
| Lercanidipine + Enalapril10/20 mg once daily for 10 weeks | Drug | Lercanidipine 10mg/Enalapril 20 mg |
| Lercanidipine + Enalapril20/10 mg once daily for 10 weeks | Drug | Lercanidipine 20mg/Enalapril 10 mg |
| Lercanidipine + Enalapril20/20 mg once daily for 10 weeks | Drug | Lercanidipine 20mg/Enalapril20mg |
Primary outcome
Change from baseline in sitting diastolic blood pressure (SDBP)
Time frame: after 10 weeks
2 secondary outcomes
Change from baseline in sitting systolic blood pressure (SSBP)
Time frame: after 10 weeks
Safety parameters: adverse events, heart rate, laboratory tests physical examination
Time frame: 10 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 29 Apr 2011.
- Derived from this study: PubMed 26630216Mancia G, Omboni S, Chazova I, Coca A, Girerd X, Haller H, Parati G, Pauletto P, Pupek-Musialik D, Svyshchenko Y; FELT Study Group. Effects of the lercanidipine-enalapril combination vs. the corresponding monotherapies on home blood pressure in hypertension: evidence from a large database. J Hypertens. 2016 Jan;34(1):139-48. doi: 10.1097/HJH.0000000000000767.
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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.
Giuseppe Mancia, Prof study chair
Clinica Medica Ospedale S. Gerardo Università Milano Bicocca Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lercanidipine, Enalapril and Lercanidipine + Enalapril in people with Essential Hypertension, run by RECORDATI GROUP at 1 site in France.
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 4 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 29 Apr 2011. 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 France. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline in sitting diastolic blood pressure (SDBP) (time frame: after 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01093807, which also lists 1 linked publication.
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 29 Apr 2011.