Endothelium, VascularNCT02885558
Role of Calcium Channels in Vascular Function
A study testing Efonidipine and Nifedipine in people with Endothelium, Vascular, run by University of Southern Denmark at 2 sites in Denmark.
Trial summary
The purpose of this study is to examine the role of T-type calcium channels in endothelial dysfunction observed with ageing. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelium, Vascular
- What is being tested?
- Efonidipine and Nifedipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Nov 2017to 25 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 20 - 30 and 60-70
- BMI < 30
Who cannot join
- Hypertension (>150/90 mmHg)
- Smoking
- Physical activity >2 hours/week
- Known chronic diseases
- Pregnancy or birth within 3 month
- Alcohol misuse
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Centre for Phsical Activity Research
Copenhagen, 2100
Cardiovascular and Renal Research
Odense, 5000
About this study
Official title: 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.
- Conditions
- Endothelium, Vascular
- Being tested
- Efonidipine, Nifedipine
- Keywords
- Receptors, Calcium Channel Blocker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfonidipineDrug
Also called Landel (efonidipine)
8 weeks treatment with either efonidipine
NifedipineDrug
Also called Adalat (nifedipine)
8 weeks treatment with either nifedipine
| Study group | Role | What they receive |
|---|---|---|
| L + T-type | Experimental | 8 weeks treatment with efonidipine (1 week 1x20mg, 7 weeks 2x20mg) Receives: Drug: Efonidipine |
| L-Type | Active comparator | 8 weeks treatment with nifedipine (1 week 1x20mg, 7 weeks 2x20mg) Receives: Drug: Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular function
Hemodynamic response to femoral arterially infused vasoactive substances
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start1 Nov 2017
- Primary completion25 May 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelium, VascularStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Mortensen, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885558
- Sponsor's protocol ID
- 47880
- Status last verified
- May 2021
- First submitted
- 26 Aug 2016
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of T-type Calcium Channels in Vascular Function
- ClinicalTrials.gov ID
- NCT02885558
- Acronym / sponsor ID
- 47880
- Conditions
- Endothelium, Vascular
- Keywords
- Receptors, Calcium Channel Blocker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the role of T-type calcium channels in endothelial dysfunction observed with ageing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L + T-type | Experimental | Drug: Efonidipine8 weeks treatment with efonidipine (1 week 1x20mg, 7 weeks 2x20mg) |
| L-Type | Active comparator | Drug: Nifedipine8 weeks treatment with nifedipine (1 week 1x20mg, 7 weeks 2x20mg) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 20 - 30 and 60-70
- BMI < 30
Key exclusion criteria (6 listed)
- Hypertension (>150/90 mmHg)
- Smoking
- Physical activity >2 hours/week
- Known chronic diseases
- Pregnancy or birth within 3 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EfonidipineAlso: Landel (efonidipine)8 weeks treatment with either efonidipine | Drug | L + T-type |
| NifedipineAlso: Adalat (nifedipine)8 weeks treatment with either nifedipine | Drug | L-Type |
Primary outcome
Vascular function
Time frame: 8 weeks
Hemodynamic response to femoral arterially infused vasoactive substances
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efonidipine and Nifedipine in people with Endothelium, Vascular, run by University of Southern Denmark at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular function (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.