HypertensionNCT00634387
Effects of Anthocyans on Cardiovascular and Sympathetic Function
A study testing Anthocyans in people with Hypertension, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
Anthocyans modify cardiovascular and sympathetic function Read more about this study
- Who is it for?
- Ages 35 to 50 years, men only
- Conditions the study is for
- Hypertension
- What is being tested?
- Anthocyans
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2008to Jun 2009
- 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 35 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Ages 35 to 50 years old
- Males
- Hypertension
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Cardiovascular and Renal Research Center, Ulleval University Hospital
Oslo, 0407
About this study
Anthocyans modify cardiovascular and sympathetic function
- Conditions
- Hypertension
- Being tested
- Anthocyans, placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnthocyansDietary supplement
Anthocyans
placeboOther
AnthocyansDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Anthocyans Receives: Dietary Supplement: Anthocyans |
| B | Placebo comparator | no effective agent Receives: Dietary Supplement: Anthocyans; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic bloodpressure and heartrate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MedPalett
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634387
- Sponsor's protocol ID
- AC2008
- Status last verified
- Feb 2010
- First submitted
- 5 Mar 2008
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anthocyans on Cardiovascular and Sympathetic Function
- ClinicalTrials.gov ID
- NCT00634387
- Acronym / sponsor ID
- AC2008
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- MedPalett
- Study start
- Mar 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 13 Mar 2008 (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.
Anthocyans modify cardiovascular and sympathetic function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Dietary Supplement: AnthocyansAnthocyans |
| B | Placebo comparator | Dietary Supplement: Anthocyans, Other: placebono effective agent |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages 35 to 50 years old
- Males
- Hypertension
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AnthocyansAnthocyans | Dietary supplement | A, B |
| placebo | Other | B |
| Anthocyans | Dietary supplement | A |
Primary outcome
Systolic bloodpressure and heartrate
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 6 Jul 2011.
Related trials for Hypertension
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Recruiting
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Heart Failure, Heart Diseases
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anthocyans in people with Hypertension, run by Ullevaal University Hospital at 1 site in Norway.
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 3 inclusion and 0 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 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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. Some participants in this study may receive a placebo. 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?
Systolic bloodpressure and heartrate. 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 6 Jul 2011.