- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02885558
Role of Calcium Channels in Vascular Function
May 28, 2021 updated by: Stefan Mortensen, University of Southern Denmark
Role of T-type Calcium Channels in Vascular Function
The purpose of this study is to examine the role of T-type calcium channels in endothelial dysfunction observed with ageing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Centre for Phsical Activity Research
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Odense, Denmark, 5000
- Cardiovascular and Renal Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 20 - 30 and 60-70
- BMI < 30
Exclusion Criteria:
- Hypertension (>150/90 mmHg)
- Smoking
- Physical activity >2 hours/week
- Known chronic diseases
- Pregnancy or birth within 3 month
- Alcohol misuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: L + T-type
8 weeks treatment with efonidipine (1 week 1x20mg, 7 weeks 2x20mg)
|
8 weeks treatment with either efonidipine
Other Names:
|
|
Active Comparator: L-Type
8 weeks treatment with nifedipine (1 week 1x20mg, 7 weeks 2x20mg)
|
8 weeks treatment with either nifedipine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vascular function
Time Frame: 8 weeks
|
Hemodynamic response to femoral arterially infused vasoactive substances
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2017
Primary Completion (Actual)
May 25, 2021
Study Completion (Actual)
May 25, 2021
Study Registration Dates
First Submitted
August 26, 2016
First Submitted That Met QC Criteria
August 30, 2016
First Posted (Estimate)
August 31, 2016
Study Record Updates
Last Update Posted (Actual)
June 1, 2021
Last Update Submitted That Met QC Criteria
May 28, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Nifedipine
- Efonidipine
Other Study ID Numbers
- 47880
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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