NCT02885558

Brief Summary

The purpose of this study is to examine the role of T-type calcium channels in endothelial dysfunction observed with ageing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

August 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

3.6 years

First QC Date

August 26, 2016

Last Update Submit

May 28, 2021

Conditions

Endothelium, Vascular

Keywords

Receptors, Calcium Channel Blocker

Outcome Measures

Primary Outcomes (1)

  • Vascular function

    Hemodynamic response to femoral arterially infused vasoactive substances

    8 weeks

Study Arms (2)

L + T-type

EXPERIMENTAL

8 weeks treatment with efonidipine (1 week 1x20mg, 7 weeks 2x20mg)

Drug: Efonidipine

L-Type

ACTIVE COMPARATOR

8 weeks treatment with nifedipine (1 week 1x20mg, 7 weeks 2x20mg)

Drug: Nifedipine

Interventions

EfonidipineDRUG

8 weeks treatment with either efonidipine

Also known as: Landel (efonidipine)
L + T-type
NifedipineDRUG

8 weeks treatment with either nifedipine

Also known as: Adalat (nifedipine)
L-Type

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 20 - 30 and 60-70
  • BMI \< 30

You may not qualify if:

  • Hypertension (\>150/90 mmHg)
  • Smoking
  • Physical activity \>2 hours/week
  • Known chronic diseases
  • Pregnancy or birth within 3 month
  • Alcohol misuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for Phsical Activity Research

Copenhagen, 2100, Denmark

Location

Cardiovascular and Renal Research

Odense, 5000, Denmark

Location

MeSH Terms

Interventions

efonidipineNifedipine

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 26, 2016

First Posted

August 31, 2016

Study Start

November 1, 2017

Primary Completion

May 25, 2021

Study Completion

May 25, 2021

Last Updated

June 1, 2021

Record last verified: 2021-05

Locations

DK(2)