- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01074281
An Observational Study to Examine the Patients With Isolated Systolic Hypertonia (ISH) Under Therapy With Eneas® (NIS ENEAS ISH)
Examination of Patients With Isolated Systolic Hypertonia (ISH) Under Therapy With ENEAS®.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects with ISH ≥ 140 / < 90 mmHg
- Subjects who declares his willingness for the participation in the examination
- Subjects aged ≥ 50 years
Exclusion Criteria:
- Subjects who are contraindicated for Eneas
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Achievement of target BP value of ≤ 140 mmHg
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recording of systolic and diastolic BP
Time Frame: 6 months
|
6 months
|
Recording of the concurrent treatments
Time Frame: 6 months
|
6 months
|
Side-effects
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neuromuscular Manifestations
- Heart Murmurs
- Hypertension
- Muscle Hypertonia
- Systolic Murmurs
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin-Converting Enzyme Inhibitors
- Enalaprilat
- Enalapril
- Nitrendipine
Other Study ID Numbers
- 084000-501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Completed
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
Clinical Trials on Enalapril maleate (10 mg) + nitrendipine (20 mg)
-
Omar Tarek ElfarargiNot yet recruiting
-
Xenon Pharmaceuticals Inc.CompletedMajor Depressive DisorderUnited States
-
Daiichi Sankyo, Inc.CompletedAtopic DermatitisUnited States
-
Intra-Cellular Therapies, Inc.Not yet recruitingHealthy VolunteersUnited States
-
Addpharma Inc.CompletedHypertension | HyperlipidemiasKorea, Republic of
-
Eisai Co., Ltd.Completed
-
Suzhou Transcenta Therapeutics Co., Ltd.Completed
-
Taisho Pharmaceutical Co., Ltd.Completed
-
Suzhou Transcenta Therapeutics Co., Ltd.Completed
-
AstraZenecaCompletedZollinger-Ellison Syndrome | Reflux Esophagitis (RE) | Gastric Ulcer (GU) | Duodenal Ulcer (DU) | Anastomotic Ulcer (AU) | Non-erosive Reflux Esophagitis Disease (NERD)Japan