HypertensionPhase 4NCT01211314
Antihypertensive Efficacy of Fixed Combination Drug
A Phase 4 study testing Lercanidipine/enalapril fixed combination in people with Hypertension, run by Meir Medical Center at 1 site in Israel.
Trial summary
Treatment and control of hypertension is still insufficient. About 50% of the patients remain uncontrolled. Lack of compliance with discontinuation of drug treatment is an important reason for not achieving blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Lercanidipine/enalapril fixed combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Apr 2012
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Essential hypertension at visit 1 defined as office blood pressure <140/90 mmHg and a 24 h ABPM >130/80 mmHg with a day time blood pressure (extracted from the 24h ABPM) >135/85 mmHg
- Male and female
- Age 18-80
- Every patient that in the medical opinion of the treating physician is eligible for Vasodip Combo 20 treatment.
- Willing to sign an informed consent
Who cannot join
- Use of more than 2 anti hypertensive medication at visit 1 (fixed combination is considered as two drugs)
- Mean 24 h ABPM values of more than 180/100 mmHg
- Pregnant women
- Women with potential age of pregnancy.
- Suspected secondary hypertension (investigator decision)
- Uncontrolled Diabetes Mellitus(investigator decision)
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- Any of the following in the last six months: Myocardial Infarction, Stroke, Coronary by-pass surgery, Percutaneous coronariography with balloon dilation and/or stent insertion
- Congestive Heart Failure requiring pharmacological treatment
- Renal Failure, defined as serum creatinine equal or great than 1.5 mg% [confirmed twice] or hyperkalemia defined as serum potassium equal or great that 5 meq/l [confirmed twice]
- Malignancy that required Chemotherapy in the last 3 years.
- Any medical or none medical condition that in the eyes of the investigator will not allow the patient to complete the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Essential Hypertension With Vasodip-Combo 20. Efficacy and Safety Evaluation With 24 h Ambulatory Blood Pressure Measurements
Treatment and control of hypertension is still insufficient. About 50% of the patients remain uncontrolled. Lack of compliance with discontinuation of drug treatment is an important reason for not achieving blood pressure. Several studies have shown that use of fixed combinations improve compliance significantly, by reducing the number of pill's intake.
This study will assess the antihypertensive efficacy of Vasodip-Combo 20® [enalapril 20 mg + lercanidipine 10 mg] as a fixed combination drug in uncontrolled antihypertensive patients.
Read the detailed description
This is a single centre observational uncontrolled prospective study, Hypertensive patients that are either treatment naïve or uncontrolled on current therapy [one or two drugs] and meet all inclusion and exclusion criteria, will be assigned to Vasodip-Combo 20 as unique drug treatment. The treatment will then be continued for additional 4 weeks. Office blood pressure will be performed by the physician at each visit. 24 h. ambulatory blood pressure measurements [ABPM] and blood samples for electrolytes, creatinine and urea will be taken at base line visit and at at week 4.
Efficacy will be defined in terms of therapeutic goals expressed as target blood pressures according to World Health Organization and European society of Hypertension [ for office blood pressure and ambulatory blood pressure measurements] criteria:
Office Blood Pressure: Diastolic blood pressure ≤ 90 mmHg and Systolic blood pressure ≤ 140 mmHg for non-diabetics or Diastolic Blood Pressure ≤ 80 mmHg and Systolic Blood Pressure ≤ 130 mmHg for diabetics, respectively.
24 h Ambulatory Blood Pressure Measurements: 224 Hour: Diastolic Blood Pressure≤ 80 mmHg and Systolic Blood Pressure ≤ 130 mmHg, Awake time: Diastolic Blood Pressure ≤ 85 mmHg,Systolic Blood Pressure ≤ 135 mmHg Asleep Time: Diastolic Blood Pressure ≤70 mmHg, Systolic Blood Pressure ≤ 70 mmHg.
Effectiveness and Safety will also be evaluated taking into consideration patient compliance
Safety assessments:
Safety will be assessed by means of (S)Adverse effects reporting.
- Conditions
- Hypertension
- Being tested
- Lercanidipine/enalapril fixed combination
- Keywords
- hypertension, Fixed combination, lercanidipine, enalapril, Blood Pressure Monitoring, Ambulatory
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lercanidipine/enalapril fixed combinationDrug
Also called Vasodip Combo 20, hypertension, ambulatory blood pressure monitoring
Lercanidipine 10 mg + enalapril 20 mg, once a day, used as a fixed combination drug. Unique dose during the study
| Study group | Role | What they receive |
|---|---|---|
| lercanidipine-enalapril fixed combination | Experimental | uncontrolled hypertensive patients will receive fixed combination therapy Receives: Drug: Lercanidipine/enalapril fixed combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure control
Percentage of patients with controlled blood pressure with office BP and 24 h ABPM measurements, from baseline to week 4.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionApr 2012
Why it stopped: sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dexcel Pharma Technologies Ltd.
- Responsible party
- Sponsor
- Investigators
- Eduardo Podjarny, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211314
- Sponsor's protocol ID
- EDU1952
- Status last verified
- Aug 2011
- First submitted
- 28 Sep 2010
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Hair PI, Scott LJ, Perry CM. Fixed-dose combination lercanidipine/enalapril. Drugs. 2007;67(1):95-106; discussion 107-8. doi: 10.2165/00003495-200767010-00007.
PubMed 17209666Menne J, Haller H. Fixed-dose lercanidipine/enalapril for hypertension. Drugs Today (Barc). 2008 Apr;44(4):261-70. doi: 10.1358/dot.2008.44.4.1164756.
PubMed 18536784Mancia G, Laurent S, Agabiti-Rosei E, Ambrosioni E, Burnier M, Caulfield MJ, Cifkova R, Clement D, Coca A, Dominiczak A, Erdine S, Fagard R, Farsang C, Grassi G, Haller H, Heagerty A, Kjeldsen SE, Kiowski W, Mallion JM, Manolis A, Narkiewicz K, Nilsson P, Olsen MH, Rahn KH, Redon J, Rodicio J, Ruilope L, Schmieder RE, Struijker-Boudier HA, Van Zwieten PA, Viigimaa M, Zanchetti A. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. Blood Press. 2009;18(6):308-47. doi: 10.3109/08037050903450468. No abstract available.
PubMed 20001654
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Essential Hypertension With Vasodip-Combo 20. Efficacy and Safety Evaluation With 24 h Ambulatory Blood Pressure Measurements
- ClinicalTrials.gov ID
- NCT01211314
- Acronym / sponsor ID
- EDU1952
- Conditions
- Hypertension
- Keywords
- hypertension, Fixed combination, lercanidipine, enalapril, Blood Pressure Monitoring, Ambulatory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor decision
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Dexcel Pharma Technologies Ltd.
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 29 Sep 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.
Treatment and control of hypertension is still insufficient. About 50% of the patients remain uncontrolled. Lack of compliance with discontinuation of drug treatment is an important reason for not achieving blood pressure. Several studies have shown that use of fixed combinations improve compliance significantly, by reducing the number of pill's intake.
This study will assess the antihypertensive efficacy of Vasodip-Combo 20® [enalapril 20 mg + lercanidipine 10 mg] as a fixed combination drug in uncontrolled antihypertensive patients.
Detailed description
This is a single centre observational uncontrolled prospective study, Hypertensive patients that are either treatment naïve or uncontrolled on current therapy [one or two drugs] and meet all inclusion and exclusion criteria, will be assigned to Vasodip-Combo 20 as unique drug treatment. The treatment will then be continued for additional 4 weeks. Office blood pressure will be performed by the physician at each visit. 24 h. ambulatory blood pressure measurements [ABPM] and blood samples for electrolytes, creatinine and urea will be taken at base line visit and at at week 4.
Efficacy will be defined in terms of therapeutic goals expressed as target blood pressures according to World Health Organization and European society of Hypertension [ for office blood pressure and ambulatory blood pressure measurements] criteria:
Office Blood Pressure: Diastolic blood pressure ≤ 90 mmHg and Systolic blood pressure ≤ 140 mmHg for non-diabetics or Diastolic Blood Pressure ≤ 80 mmHg and Systolic Blood Pressure ≤ 130 mmHg for diabetics, respectively.
24 h Ambulatory Blood Pressure Measurements: 224 Hour: Diastolic Blood Pressure≤ 80 mmHg and Systolic Blood Pressure ≤ 130 mmHg, Awake time: Diastolic Blood Pressure ≤ 85 mmHg,Systolic Blood Pressure ≤ 135 mmHg Asleep Time: Diastolic Blood Pressure ≤70 mmHg, Systolic Blood Pressure ≤ 70 mmHg.
Effectiveness and Safety will also be evaluated taking into consideration patient compliance
Safety assessments:
Safety will be assessed by means of (S)Adverse effects reporting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lercanidipine-enalapril fixed combination | Experimental | Drug: Lercanidipine/enalapril fixed combinationuncontrolled hypertensive patients will receive fixed combination therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Essential hypertension at visit 1 defined as office blood pressure <140/90 mmHg and a 24 h ABPM >130/80 mmHg with a day time blood pressure (extracted from the 24h ABPM) >135/85 mmHg
- Male and female
- Age 18-80
- Every patient that in the medical opinion of the treating physician is eligible for Vasodip Combo 20 treatment.
- Willing to sign an informed consent
Key exclusion criteria (11 listed)
- Use of more than 2 anti hypertensive medication at visit 1 (fixed combination is considered as two drugs)
- Mean 24 h ABPM values of more than 180/100 mmHg
- Pregnant women
- Women with potential age of pregnancy.
- Suspected secondary hypertension (investigator decision)
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/enalapril fixed combinationAlso: Vasodip Combo 20, hypertension, ambulatory blood pressure monitoringLercanidipine 10 mg + enalapril 20 mg, once a day, used as a fixed combination drug. Unique dose during the study | Drug | lercanidipine-enalapril fixed combination |
Primary outcome
Blood Pressure control
Time frame: Four weeks
Percentage of patients with controlled blood pressure with office BP and 24 h ABPM measurements, from baseline to week 4.
Results and safety
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Background: PubMed 17209666Hair PI, Scott LJ, Perry CM. Fixed-dose combination lercanidipine/enalapril. Drugs. 2007;67(1):95-106; discussion 107-8. doi: 10.2165/00003495-200767010-00007.
- Background: PubMed 18536784Menne J, Haller H. Fixed-dose lercanidipine/enalapril for hypertension. Drugs Today (Barc). 2008 Apr;44(4):261-70. doi: 10.1358/dot.2008.44.4.1164756.
- Background: PubMed 20001654Mancia G, Laurent S, Agabiti-Rosei E, Ambrosioni E, Burnier M, Caulfield MJ, Cifkova R, Clement D, Coca A, Dominiczak A, Erdine S, Fagard R, Farsang C, Grassi G, Haller H, Heagerty A, Kjeldsen SE, Kiowski W, Mallion JM, Manolis A, Narkiewicz K, Nilsson P, Olsen MH, Rahn KH, Redon J, Rodicio J, Ruilope L, Schmieder RE, Struijker-Boudier HA, Van Zwieten PA, Viigimaa M, Zanchetti A. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. Blood Press. 2009;18(6):308-47. doi: 10.3109/08037050903450468. No abstract available.
- Individual participant dataSharing planned: Yes
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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.
Eduardo Podjarny, MD principal investigator
Clalit Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lercanidipine/enalapril fixed combination in people with Hypertension, run by Meir Medical Center at 1 site in Israel.
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 5 inclusion and 11 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 28 Jun 2016. 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 Israel. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: sponsor decision). 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?
Blood Pressure control (time frame: Four 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 NCT01211314, which also lists 3 linked publications.
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 28 Jun 2016.