HypertensionPhase 1/2NCT02663479
Nutraceutical Supplement in the Management of Hypertension
A Phase 1/2 study testing Cardiopressin in people with Hypertension, run by Thorne HealthTech, Inc at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of a proprietary nutraceutical supplement in capsule form over 4 months in treating blood pressure in a group of chronic hypertensive subjects that are not receiving any pharmaceutical anti-hypertensive agents or other nutraceutical supplements. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Cardiopressin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Oct 2017
- Phase
- Phase 1/2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with chronic hypertension: Blood pressure at study entry must be greater than or equal to systolic blood pressure of 140 mm Hg but less than 180 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg but less than 105 mm Hg
- Subjects are not taking any prescription anti-hypertensive drugs.
- Subjects must be off all nutraceutical supplements for at least 30 days prior to entry into the study.
Who cannot join
- Myocardial infarction, PTCA , stent, CABG within 5 years, known clinical CHD or clinical angina.
- History of cerebrovascular accident (CVA).
- Creatinine over 2.5 mg/dL.
- Known allergy or sensitivity to any components of the study blood pressure supplement.
- Chronic liver disease with AST, ALT, alkaline phosphatase over 1.5 x normal lab values.
- Known cancer within 2 years.
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- Clinical congestive heart failure ( systolic or diastolic CHF)
- Pregnant and nursing women and women.
- Women of child bearing age not on approved contraception control.
- Type 1 and Type 2 diabetes mellitus on medications.
- If the study subjects develop BP over 180 mm Hg systolic or 110 mm Hg diastolic during the study, they will be discontinued from the study and the investigator will immediately start rescue drug therapy for BP control.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hypertension Institute of Nashville, TN
Nashville, Tennessee, 37205
About this study
Official title: Proprietary Lipid-Lowering Nutraceutical Supplement in the Management of Hypertension
The purpose of this study is to evaluate the efficacy and safety of a proprietary nutraceutical supplement in capsule form over 4 months in treating blood pressure in a group of chronic hypertensive subjects that are not receiving any pharmaceutical anti-hypertensive agents or other nutraceutical supplements.
- Conditions
- Hypertension
- Being tested
- Cardiopressin, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiopressinDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Cardiopressin | Experimental | A 5 capsule proprietary blend of herbal extracts and nutrients Receives: Dietary Supplement: Cardiopressin |
| Placebo | Placebo comparator | A 5 capsule placebo matched in color and size to the Experimental supplement Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Reduction in systolic and diastolic blood pressure as measured by office readings and 24 hour ABM ( ambulatory blood pressure monitor)
Measured: 4 months
Secondary outcomes (4)
Endothelial Function
Measured via Endopat
Measured: 4 months
Small arterial compliance
Measured via computerized arterial pulse wave analysis (CAPWA)
Measured: 4 months
Large arterial compliance
Measured via computerized arterial pulse wave analysis (CAPWA)
Measured: 4 months
Central arterial blood pressure
Measured via computerized arterial pulse wave analysis (CAPWA)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionAug 2017
- Study completionOct 2017
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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thorne HealthTech, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Houston, MD, MS, MSc, Principal investigator, Hypertension InstituteBodi Zhang, MD, MPH, PhD, Principal investigator, Thorne Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663479
- Sponsor's protocol ID
- TruCardia-002
- Status last verified
- Mar 2020
- First submitted
- 18 Jan 2016
- Last updated
- 13 Mar 2020
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprietary Lipid-Lowering Nutraceutical Supplement in the Management of Hypertension
- ClinicalTrials.gov ID
- NCT02663479
- Acronym / sponsor ID
- TruCardia-002
- Conditions
- Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Thorne HealthTech, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 Jan 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 evaluate the efficacy and safety of a proprietary nutraceutical supplement in capsule form over 4 months in treating blood pressure in a group of chronic hypertensive subjects that are not receiving any pharmaceutical anti-hypertensive agents or other nutraceutical supplements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiopressin | Experimental | Dietary Supplement: CardiopressinA 5 capsule proprietary blend of herbal extracts and nutrients |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboA 5 capsule placebo matched in color and size to the Experimental supplement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with chronic hypertension: Blood pressure at study entry must be greater than or equal to systolic blood pressure of 140 mm Hg but less than 180 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg but less than 105 mm Hg
- Subjects are not taking any prescription anti-hypertensive drugs.
- Subjects must be off all nutraceutical supplements for at least 30 days prior to entry into the study.
Key exclusion criteria (11 listed)
- Myocardial infarction, PTCA , stent, CABG within 5 years, known clinical CHD or clinical angina.
- History of cerebrovascular accident (CVA).
- Creatinine over 2.5 mg/dL.
- Known allergy or sensitivity to any components of the study blood pressure supplement.
- Chronic liver disease with AST, ALT, alkaline phosphatase over 1.5 x normal lab values.
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 |
|---|---|---|
| Cardiopressin | Dietary supplement | Cardiopressin |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Blood Pressure
Time frame: 4 months
Reduction in systolic and diastolic blood pressure as measured by office readings and 24 hour ABM ( ambulatory blood pressure monitor)
4 secondary outcomes
Endothelial Function
Time frame: 4 months
Small arterial compliance
Time frame: 4 months
Large arterial compliance
Time frame: 4 months
Central arterial blood pressure
Time frame: 4 months
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 13 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Mark Houston, MD, MS, MSc principal investigator
Hypertension Institute
Bodi Zhang, MD, MPH, PhD principal investigator
Thorne Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cardiopressin in people with Hypertension, run by Thorne HealthTech, Inc at 1 site in United States.
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 11 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 13 Mar 2020. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Blood Pressure (time frame: 4 months). 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 13 Mar 2020.