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An Observational Study to Examine the Patients With Isolated Systolic Hypertonia (ISH) Under Therapy With Eneas® (NIS ENEAS ISH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01074281
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : February 19, 2014
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Brief 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.

Condition or disease Intervention/treatment
Hypertension Drug: Enalapril maleate (10 mg) + nitrendipine (20 mg)

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.


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)

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Study Type : Observational
Actual Enrollment : 2065 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Examination of Patients With Isolated Systolic Hypertonia (ISH) Under Therapy With ENEAS®.
Study Start Date : June 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Enalapril maleate (10 mg) + nitrendipine (20 mg)
    The drug was administered as per the Summary of Product Characteristics (SPC)
    Other Name: Eneas

Primary Outcome Measures :
  1. Achievement of target BP value of ≤ 140 mmHg [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Recording of systolic and diastolic BP [ Time Frame: 6 months ]
  2. Recording of the concurrent treatments [ Time Frame: 6 months ]
  3. Side-effects [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with ISH ≥ 140 / < 90 mmHg were enrolled in the study.

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
Publications of Results:
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.

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Responsible Party: Merck KGaA, Darmstadt, Germany Identifier: NCT01074281    
Other Study ID Numbers: 084000-501
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014
Keywords provided by Merck KGaA, Darmstadt, Germany:
Isolated systolic hypertonia
Additional relevant MeSH terms:
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Muscle Hypertonia
Vascular Diseases
Cardiovascular Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents