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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01074281
First received: February 22, 2010
Last updated: February 16, 2014
Last verified: February 2014
  Purpose

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 Intervention
Hypertension
Drug: Enalapril maleate (10 mg) + nitrendipine (20 mg)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Examination of Patients With Isolated Systolic Hypertonia (ISH) Under Therapy With ENEAS®.

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Achievement of target BP value of ≤ 140 mmHg [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recording of systolic and diastolic BP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Recording of the concurrent treatments [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Side-effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 2065
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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
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)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects with ISH ≥ 140 / < 90 mmHg were enrolled in the study.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01074281     History of Changes
Other Study ID Numbers: 084000-501
Study First Received: February 22, 2010
Last Updated: February 16, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Merck KGaA:
Hypertension
Isolated systolic hypertonia
Eneas

Additional relevant MeSH terms:
Hypertension
Muscle Hypertonia
Cardiovascular Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms
Vascular Diseases
Enalapril
Enalaprilat
Nitrendipine
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 30, 2014