HypertensionNCT01074281
An Observational Study to Examine the Patients With Isolated Systolic Hypertonia (ISH) Under Therapy With Eneas® (NIS ENEAS ISH)
An observational study of Hypertension, run by Merck KGaA, Darmstadt, Germany.
Trial summary
This non interventional, multicentric, uncontrolled, prospective, observational study was planned to observe the course of disease in subjects with ISH, who were treated with Eneas. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Enalapril maleate (10 mg) + nitrendipine (20 mg)
- How many people
- 2,065 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Aug 2009
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with ISH ≥ 140 / < 90 mmHg were enrolled in the study.
Who may be able to join
- Subjects with ISH ≥ 140 / < 90 mmHg
- Subjects who declares his willingness for the participation in the examination
- Subjects aged ≥ 50 years
Who cannot join
- Subjects who are contraindicated for Eneas
About this study
Official title: Examination of Patients With Isolated Systolic Hypertonia (ISH) Under Therapy With ENEAS®.
This non interventional, multicentric, uncontrolled, prospective, observational study was planned to observe the course of disease in subjects with ISH, who were treated with Eneas.
Read the detailed description
Isolated systolic hypertonia is an autonomous form of the hypertonia, which in 73% of cases develops from a normal blood pressure (BP) situation. A strict BP control is especially important in older people, since the incidence of the ISH also increases with increasing age. This can be attributed to the elasticity of the vessels reducing with the age. Systolic Hypertension in Elderly Program (SHEP) study has shown ISH to be an independent cardiovascular risk factor.
Eneas is a combination of angiotensin converting enzyme (ACE) inhibitor enalapril maleate (10 mg) and the calcium antagonist nitrendipine (20 mg). Irrespective of the fact as shown in different studies, that calcium-antagonists as also ACE inhibitors have an especially distinctive potential for the degeneration of a left-ventricular hypertrophy (LVH). Examinations like the SYST-EUR-study has demonstrated the high therapeutic potential of the combination of nitrendipine and enalapril in older hypertonia subjects. It was proven in this multicentric, double-blind, randomised and placebo controlled study, that when the additional dose of enalapril (and if necessary diuretics was administered) in subjects with ISH above 60 years under treatment with nitrendipine and in case of not sufficient lowering of BP, the total incidence of cardiac events (heart failure, ischaemic heart disease and sudden heart fall) was reduced by 26% within two years of treatment. As part of the SYST-EUR study, a reduction of the incidence of vascular dementia by 50% was documented in the so-called "Vascular Dementia Project" with standardised psychometric measuring system. This effect was probably attributed not alone to the lowering of BP, but also to the additive ZNS-protective effects of nitrendipine and enalapril.
OBJECTIVES
Primary objective:
- To observe the course of disease in subjects with ISH, who were treated with Eneas. In this case, particular attention was given to achievement of target value in the lowering of the systolic BP value (< 140 mmHg) within a 6 month treatment time period.
Secondary objectives:
- To examine the systolic as well as diastolic BP situation and the total medication, especially medication for the therapy of the ISH across the treatment duration
- To collect the drug security data in the examined subject group under practical conditions
The examination plan of this study included approximately the examinations given below, whereby the time of the individual examinations were subjected exclusively to the clinical requirements and the usual conventions in the centre:
- Examination at the beginning of the treatment (Visit 1)
- Control examination after approximately 3 months (Visit 2)
- Control examination after approximately 6 months (Visit 3)
- Conditions
- Hypertension
- Being tested
- Enalapril maleate (10 mg) + nitrendipine (20 mg)
- Keywords
- Hypertension, Isolated systolic hypertonia, Eneas
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enalapril maleate (10 mg) + nitrendipine (20 mg)Drug
Also called Eneas
The drug was administered as per the Summary of Product Characteristics (SPC)
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of target BP value of ≤ 140 mmHg
Measured: 6 months
Secondary outcomes (3)
Recording of systolic and diastolic BP
Measured: 6 months
Recording of the concurrent treatments
Measured: 6 months
Side-effects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startJun 2008
- Primary completionAug 2009
- Study completionAug 2009
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,065 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074281
- Sponsor's protocol ID
- 084000-501
- Status last verified
- Feb 2014
- First submitted
- 22 Feb 2010
- Last updated
- 19 Feb 2014
- Results posted
- No
Publications
Trenkwalder, P. (2010). Fixkombination von Enalapril und Nitrendipin bei isoliert systolischer Hypertonie - Wirksamkeit und Verträglichkeit in der täglichen Praxis. Ergebnisse einer multizentrischen, 6-monatigen nichtinterventionellen Studie Perfusion, 23(2), 66.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Patients With Isolated Systolic Hypertonia (ISH) Under Therapy With ENEAS®.
- ClinicalTrials.gov ID
- NCT01074281
- Acronym / sponsor ID
- 084000-501
- Conditions
- Hypertension
- Keywords
- Hypertension, Isolated systolic hypertonia, Eneas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,065 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 24 Feb 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.
This non interventional, multicentric, uncontrolled, prospective, observational study was planned to observe the course of disease in subjects with ISH, who were treated with Eneas.
Detailed description
Isolated systolic hypertonia is an autonomous form of the hypertonia, which in 73% of cases develops from a normal blood pressure (BP) situation. A strict BP control is especially important in older people, since the incidence of the ISH also increases with increasing age. This can be attributed to the elasticity of the vessels reducing with the age. Systolic Hypertension in Elderly Program (SHEP) study has shown ISH to be an independent cardiovascular risk factor.
Eneas is a combination of angiotensin converting enzyme (ACE) inhibitor enalapril maleate (10 mg) and the calcium antagonist nitrendipine (20 mg). Irrespective of the fact as shown in different studies, that calcium-antagonists as also ACE inhibitors have an especially distinctive potential for the degeneration of a left-ventricular hypertrophy (LVH). Examinations like the SYST-EUR-study has demonstrated the high therapeutic potential of the combination of nitrendipine and enalapril in older hypertonia subjects. It was proven in this multicentric, double-blind, randomised and placebo controlled study, that when the additional dose of enalapril (and if necessary diuretics was administered) in subjects with ISH above 60 years under treatment with nitrendipine and in case of not sufficient lowering of BP, the total incidence of cardiac events (heart failure, ischaemic heart disease and sudden heart fall) was reduced by 26% within two years of treatment. As part of the SYST-EUR study, a reduction of the incidence of vascular dementia by 50% was documented in the so-called "Vascular Dementia Project" with standardised psychometric measuring system. This effect was probably attributed not alone to the lowering of BP, but also to the additive ZNS-protective effects of nitrendipine and enalapril.
OBJECTIVES
Primary objective:
- To observe the course of disease in subjects with ISH, who were treated with Eneas. In this case, particular attention was given to achievement of target value in the lowering of the systolic BP value (< 140 mmHg) within a 6 month treatment time period.
Secondary objectives:
- To examine the systolic as well as diastolic BP situation and the total medication, especially medication for the therapy of the ISH across the treatment duration
- To collect the drug security data in the examined subject group under practical conditions
The examination plan of this study included approximately the examinations given below, whereby the time of the individual examinations were subjected exclusively to the clinical requirements and the usual conventions in the centre:
- Examination at the beginning of the treatment (Visit 1)
- Control examination after approximately 3 months (Visit 2)
- Control examination after approximately 6 months (Visit 3)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with ISH ≥ 140 / < 90 mmHg were enrolled in the study.
Key inclusion criteria (3 listed)
- Subjects with ISH ≥ 140 / < 90 mmHg
- Subjects who declares his willingness for the participation in the examination
- Subjects aged ≥ 50 years
Key exclusion criteria (1 listed)
- Subjects who are contraindicated for Eneas
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 |
|---|---|---|
| Enalapril maleate (10 mg) + nitrendipine (20 mg)Also: EneasThe drug was administered as per the Summary of Product Characteristics (SPC) | Drug | – |
Primary outcome
Achievement of target BP value of ≤ 140 mmHg
Time frame: 6 months
3 secondary outcomes
Recording of systolic and diastolic BP
Time frame: 6 months
Recording of the concurrent treatments
Time frame: 6 months
Side-effects
Time frame: 6 months
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 19 Feb 2014.
- Results publicationTrenkwalder, P. (2010). Fixkombination von Enalapril und Nitrendipin bei isoliert systolischer Hypertonie - Wirksamkeit und Verträglichkeit in der täglichen Praxis. Ergebnisse einer multizentrischen, 6-monatigen nichtinterventionellen Studie Perfusion, 23(2), 66.
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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 Merck KGaA, Darmstadt, Germany.
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 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 19 Feb 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?
Achievement of target BP value of ≤ 140 mmHg (time frame: 6 months). 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 NCT01074281, 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 19 Feb 2014.