HypertensionPhase 1/2NCT02133885
Study 2: Effect of Minocycline Treatment on Drug-Resistant Hypertensive Patients
A Phase 1/2 study testing Minocycline Group in people with Hypertension, run by University of Florida at 1 site in United States.
Trial summary
Hypertension (HTN) is the single most prevalent risk factor for cardiovascular disease, diabetes, obesity and metabolic syndrome. Despite advances in life style modification and multi-drug therapies, 20-30% of all hypertensive patients remain resistant. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Minocycline Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2023to Mar 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 18 and less than 86 years of age;
- On stable medication regimen
- o Full-tolerated doses of 3 or more anti-hypertensive medications of different classes, one of which must be a diuretic (with no changes for a minimum of two months prior to screening) that is expected to be maintained without changes for at least 3 months.
- Office systolic blood pressure (SBP) of greater than 160 mmHg based on an average of 3 blood pressure readings measured at both initial screening visit
- The individual agrees to have all study procedures performed
- Willing to provide written consent
- Females with childbearing potential must not be pregnant.
Who cannot join
- eGFR of < 45 mL/min/1.73m2, using the MDRD calculation.
- More than one in-patient hospitalization for an anti-hypertensive crisis within the year.
- More than one episode(s) of orthostatic hypotension (reduction of SBP of ≥ 20 mmHg of diastolic blood pressure (DBP) of ≥ 10 mmHg within 3 minutes of standing).
- History of myocardial infarction (MI), unstable angina pectoris, syncope or a cardiovascular accident within 6 months of screening period
- Clinically significant atrioventricular (AV) conduction disturbances and/or arrhythmias (e.g. 2nd or 3rd degree AV block);
- Current of past history of heart failure (≤40% left ventricular ejection fraction (EF).
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- Major of psychotropic agents and antidepressants.
- Use of nonsteroidal anti-inflammatory drug (NSAIDs)
- Known hypersensitivity or contraindication to Minocycline or other tetracycline.
- Smoking
- Concurrent severe disease (such as neoplasm or HIV positive or AIDS).
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Cardiovascular Clinic
Gainesville, Florida, 32610
About this study
Official title: Angiotensin and Neuroimmune Activation in Hypertension
Hypertension (HTN) is the single most prevalent risk factor for cardiovascular disease, diabetes, obesity and metabolic syndrome. Despite advances in life style modification and multi-drug therapies, 20-30% of all hypertensive patients remain resistant.
These individuals exhibit autonomic dysregulation due to elevated sympathetic activity and norepinephrine spillover, and low parasympathetic activity. It is generally accepted that this uncontrolled, resistant HTN is primarily "neurogenic" in origin, involving over activity of the sympathetic nervous system that initiates and sustains HTN. Thus, a mechanism-based breakthrough is imperative to develop novel strategies to prevent and perhaps eventually cure neurogenic hypertension (NH).
This study is a double-blind, placebo-controlled, cross-over design to test the hypothesis that minocycline treatment would produce antihypertensive effects in drug-resistant neurogenic hypertensive individuals.
Read the detailed description
This is a double-blind, placebo-controlled, cross over design to evaluate the effects of minocycline in patients with resistent hypertension. After providing informed consent, patients will have baseline and followup visits during which a brief physical examination will be performed, medical history, assessment of medication compliance and tolerance, and vital signs will be completed.
Subjects will undergo blood (lipid panel, high sensitivity-C reactive protein, high sensitivity troponin, glucose, metabolic profile, lipid panel, Cystatin C and albumin) and urine studies at the baseline visit and at 16, 19, 35 and 54 weeks. Patients will have ambulatory BP monitoring at baseline and at the end of each treatment period.
Patients will be randomized to drug scheme A or B. One scheme will follow the following order: 16 weeks of minocycline, followed by a 3 week wash out period, then 16 weeks of placebo, then 3 weeks of wash out and a final 16 week period of minocycline. The other scheme will consist of 16 weeks of placebo, followed by 3 week wash out period, followed by 16 weeks of minocycline, then 3 week wash out and a final 16 weeks of placebo. Study visits will occur at study entry (baseline/randomization), 16 weeks, 19 weeks, 35 weeks, 38 weeks, and 54 weeks for each group. Patient participation will end after 56 weeks.
- Conditions
- Hypertension
- Being tested
- Minocycline Group, Placebo Group
- Keywords
- Resistent Hypertension, Systolic Blood Pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline GroupDrug
These subjects will start with minocycline for 16 weeks, followed by a washout period for 3 weeks, then will receive a placebo for 16 weeks, followed by a washout period for 3 weeks, then will finish with minocycline for 16 weeks.
Placebo GroupOther
These subjects will start with placebo (tablet looking just like minocycline) for 16 weeks, followed by a washout period for 3 weeks, then will receive minocycline for 16 weeks, followed by a washout period for 3 weeks, then will finish with placebo for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Minocycline Group | Active comparator | These subjects will start with minocycline for 16 weeks, followed by a washout period for 3 weeks, then will receive a placebo for 16 weeks, followed by a washout period for 3 weeks, then will finish with minocycline for 16 weeks. Receives: Drug: Minocycline Group |
| Placebo Group | Placebo comparator | These subjects will start with placebo (this will look like minocycline) for 16 weeks, followed by a washout period for 3 weeks, then will receive a minocycline for 16 weeks, followed by a washout period for 3 weeks, then will finish with placebo for 16 weeks. Receives: Other: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of ambulatory blood pressure
Change in systolic blood pressure.
Measured: Change in baseline to week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study start30 Jan 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: This study was never started and no participants were enrolled.
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.
- More trials run by University of FloridaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Carl Pepine, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133885
- Sponsor's protocol ID
- IRB201500594-N
- Other IDs
- RO1HL3361028, 2013-00102 Study 2, R01HL132448-01
- Status last verified
- Jan 2024
- First submitted
- 6 May 2014
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiotensin and Neuroimmune Activation in Hypertension
- ClinicalTrials.gov ID
- NCT02133885
- Acronym / sponsor ID
- IRB201500594-N
- Conditions
- Hypertension
- Keywords
- Resistent Hypertension, Systolic Blood Pressure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was never started and no participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 30 Jan 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 8 May 2014 (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.
Hypertension (HTN) is the single most prevalent risk factor for cardiovascular disease, diabetes, obesity and metabolic syndrome. Despite advances in life style modification and multi-drug therapies, 20-30% of all hypertensive patients remain resistant.
These individuals exhibit autonomic dysregulation due to elevated sympathetic activity and norepinephrine spillover, and low parasympathetic activity. It is generally accepted that this uncontrolled, resistant HTN is primarily "neurogenic" in origin, involving over activity of the sympathetic nervous system that initiates and sustains HTN. Thus, a mechanism-based breakthrough is imperative to develop novel strategies to prevent and perhaps eventually cure neurogenic hypertension (NH).
This study is a double-blind, placebo-controlled, cross-over design to test the hypothesis that minocycline treatment would produce antihypertensive effects in drug-resistant neurogenic hypertensive individuals.
Detailed description
This is a double-blind, placebo-controlled, cross over design to evaluate the effects of minocycline in patients with resistent hypertension. After providing informed consent, patients will have baseline and followup visits during which a brief physical examination will be performed, medical history, assessment of medication compliance and tolerance, and vital signs will be completed.
Subjects will undergo blood (lipid panel, high sensitivity-C reactive protein, high sensitivity troponin, glucose, metabolic profile, lipid panel, Cystatin C and albumin) and urine studies at the baseline visit and at 16, 19, 35 and 54 weeks. Patients will have ambulatory BP monitoring at baseline and at the end of each treatment period.
Patients will be randomized to drug scheme A or B. One scheme will follow the following order: 16 weeks of minocycline, followed by a 3 week wash out period, then 16 weeks of placebo, then 3 weeks of wash out and a final 16 week period of minocycline. The other scheme will consist of 16 weeks of placebo, followed by 3 week wash out period, followed by 16 weeks of minocycline, then 3 week wash out and a final 16 weeks of placebo. Study visits will occur at study entry (baseline/randomization), 16 weeks, 19 weeks, 35 weeks, 38 weeks, and 54 weeks for each group. Patient participation will end after 56 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline Group | Active comparator | Drug: Minocycline GroupThese subjects will start with minocycline for 16 weeks, followed by a washout period for 3 weeks, then will receive a placebo for 16 weeks, followed by a washout period for 3 weeks, then will finish with minocycline for 16 weeks. |
| Placebo Group | Placebo comparator | Other: Placebo GroupThese subjects will start with placebo (this will look like minocycline) for 16 weeks, followed by a washout period for 3 weeks, then will receive a minocycline for 16 weeks, followed by a washout period for 3 weeks, then will finish with placebo for 16 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Greater than 18 and less than 86 years of age;
- On stable medication regimen
- o Full-tolerated doses of 3 or more anti-hypertensive medications of different classes, one of which must be a diuretic (with no changes for a minimum of two months prior to screening) that is expected to be maintained without changes for at least 3 months.
- Office systolic blood pressure (SBP) of greater than 160 mmHg based on an average of 3 blood pressure readings measured at both initial screening visit
- The individual agrees to have all study procedures performed
Key exclusion criteria (11 listed)
- eGFR of < 45 mL/min/1.73m2, using the MDRD calculation.
- More than one in-patient hospitalization for an anti-hypertensive crisis within the year.
- More than one episode(s) of orthostatic hypotension (reduction of SBP of ≥ 20 mmHg of diastolic blood pressure (DBP) of ≥ 10 mmHg within 3 minutes of standing).
- History of myocardial infarction (MI), unstable angina pectoris, syncope or a cardiovascular accident within 6 months of screening period
- Clinically significant atrioventricular (AV) conduction disturbances and/or arrhythmias (e.g. 2nd or 3rd degree AV block);
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 |
|---|---|---|
| Minocycline GroupThese subjects will start with minocycline for 16 weeks, followed by a washout period for 3 weeks, then will receive a placebo for 16 weeks, followed by a washout period for 3 weeks, then will finish with minocycline for 16 weeks. | Drug | Minocycline Group |
| Placebo GroupThese subjects will start with placebo (tablet looking just like minocycline) for 16 weeks, followed by a washout period for 3 weeks, then will receive minocycline for 16 weeks, followed by a washout period for 3 weeks, then will finish with placebo for 16 weeks. | Other | Placebo Group |
Primary outcome
Reduction of ambulatory blood pressure
Time frame: Change in baseline to week 54
Change in systolic blood pressure.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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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.
Carl Pepine, MD principal investigator
University of Florida
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 Minocycline Group in people with Hypertension, run by University of Florida 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 7 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: withdrawn, as of the sponsor's last update on 1 Feb 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Reduction of ambulatory blood pressure (time frame: Change in baseline to week 54). 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 Feb 2024.