NCT01074281

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,065

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

1.2 years

First QC Date

February 22, 2010

Last Update Submit

February 16, 2014

Conditions

Hypertension

Keywords

HypertensionIsolated systolic hypertoniaEneas

Outcome Measures

Primary Outcomes (1)

  • Achievement of target BP value of ≤ 140 mmHg

    6 months

Secondary Outcomes (3)

  • Recording of systolic and diastolic BP

    6 months

  • Recording of the concurrent treatments

    6 months

  • Side-effects

    6 months

Interventions

Enalapril maleate (10 mg) + nitrendipine (20 mg)DRUG

The drug was administered as per the Summary of Product Characteristics (SPC)

Also known as: Eneas

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Subjects with ISH ≥ 140 / \< 90 mmHg
  • Subjects who declares his willingness for the participation in the examination
  • Subjects aged ≥ 50 years

You may not qualify if:

  • Subjects who are contraindicated for Eneas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

Hypertension

Interventions

EnalaprilNitrendipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 24, 2010

Study Start

June 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

February 19, 2014

Record last verified: 2014-02