NCT01390701

Brief Summary

The purpose of this study is to compare the blood pressure reducing property of transcutaneous electrical nerve stimulation with the blood pressure reducing drug felodipin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

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

January 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
Last Updated

July 11, 2011

Status Verified

June 1, 2011

Enrollment Period

1.7 years

First QC Date

July 7, 2011

Last Update Submit

July 7, 2011

Conditions

Hypertension

Keywords

randomizedcross-overtranscutaneous electrical nerve stimulationfelodipinhypertensionblood pressuretreatment

Outcome Measures

Primary Outcomes (1)

  • Blood pressure reduction

    Office blood pressure measurement and 24-h ambulatory blood pressure monitoring after four week periods of treatment in a cross-over design with intervening four week washout and subsequent four week follow-up

    four weeks

Study Arms (2)

transcutaneous electr. nerve stimulation

EXPERIMENTAL
Device: transcutaneous electrical nerve stimulation

felodipin

ACTIVE COMPARATOR
Drug: felodipin

Interventions

transcutaneous electrical nerve stimulationDEVICE

30 min of bi-daily low-frequency transcutaneous electrical nerve stimulation on the upper extremities. Duration: 28+-4 days.

Also known as: 2 Hz Primo Pro stimulators (CefarCompex, Sweden).
transcutaneous electr. nerve stimulation
felodipinDRUG

2,5mg of felodipin once daily. Duration: 28+-4 days.

felodipin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of hypertension, untreated or currently treated with a maximum of one blood pressure (BP) lowering agent

You may not qualify if:

  • systolic blood pressure \>170 mmHg and/or diastolic blood pressure of \>105 mmHg
  • second- or third-degree atrioventricular block
  • current use of opiates or other intoxicants
  • neurological disorders (such as Parkinson's disease, multiple sclerosis or peripheral neuropathy)
  • need of treatment with TENS, regardless the reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Geriatrics and Emergency Medicine, Sahlgrenska University Hospital/Östra

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Hypertension

Interventions

Transcutaneous Electric Nerve StimulationFelodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jonas Silverdal, MD

    Department of Medicine, Geriatrics and Emergency Medicine, Sahlgrenska University Hospital/Östra

    PRINCIPAL INVESTIGATOR

  • Karin Manhem, ass.prof.

    Institute of Medicine, Department of Emergency and Cardiovascular Medicine, Sahlgrenska University Hospital/Sahlgrenska

    PRINCIPAL INVESTIGATOR

  • Clas Mannheimer, professor

    Multidisciplinary Pain Center, Sahlgrenska University Hospital/Östra

    PRINCIPAL INVESTIGATOR

  • Georgios Mourtzinis, MD

    Department of Medicine, Sahlgrenska University Hospital/Mölndal

    PRINCIPAL INVESTIGATOR

  • Elisabet Stener-Victorin, ass.prof.

    Institute of Neuroscience and Physiology, Department of Physiology, University of Gothenburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 11, 2011

Study Start

January 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

July 11, 2011

Record last verified: 2011-06

Locations

SE(1)