Arterial HypertensionPhase 1/2CHAMPNCT02709031
Cicletanine in Hypertension With Diabetes: Added Magnesium Preserves Potassium and Sodium
A Phase 1/2 study testing Cicletanine + magnesium and Cicletanine in people with Arterial Hypertension and Diabetes, run by Navitas Pharma.
Trial summary
Cicletanine, which has been approved and launched for hypertension in France and Germany, has promise beyond hypertension in critically-unmet needs such as diabetes. It is evident from in vitro, animal and human studies that cicletanine's optimal dose in diabetes and other challenging, critically-unmet needs is likely… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arterial Hypertension, Diabetes, Hypokalemia
- What is being tested?
- Cicletanine + magnesium and Cicletanine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sitting SBP (systolic blood pressure) > 150 mmHg (millimeters of mercury) after five minutes' rest.
- Type II diabetes, with HbA1c between 8.5 and 11.5%. If a patient at screening presents outside of this range, the investigator may elect to re-screen a patient once to determine further the patient's eligibility.
- Age >18 and < 80 years of age
- BMI between 20 and 35, inclusive
- Have been stable on existing therapy for at least 30 days prior to initiation of cicletanine (Visit 2)
- no change in antihypertensive nor antihyperglycemia agent dose within 30 days prior to screening visit.
Show all 9Show fewer
- Willing to comply with the requirements of the protocol.
- Willing to provide written Informed Consent to participate in the study approved by an appropriately constituted IRB (Institutional Review Board).
- All females who are not post-menopausal should be using at least two forms of contraception during the entire study.
Who cannot join
- Use of potassium supplementation over the past 30 days
- Use of potassium-wasting diuretics, e. g., thiazides over the past 30 days
- AST (aspartate aminotransferase; also abbreviated SGOT) outside normal range of 5 and 40 mg/dL inclusive
- ALT (alanine aminotransferase; also abbreviated SGPT) outside normal range of 7 and 56 mg/dL inclusive
- Laboratory findings outside of normal range can be considered grounds for exclusion at the discretion of the Sponsor, Medical Monitor and / or Principal Investigator
- History of or positive laboratory test for HIV, HBV (hepatitis B virus) or HCV (hepatitis C virus)
Show all 15Show fewer
- Clinically significant psychiatric, addictive or neurologic disease or any other condition that, in the Investigator's opinion, would compromise his/her ability to give informed consent, participate fully in this study, or prevent adherence to the requirements of the study protocol
- Evidence of unstable cardiovascular disease including intermittent atrial fibrillation or unstable angina within the 4 weeks prior to screening
- History of myocardial infarction, coronary artery bypass graft surgery, or percutaneous cardiac intervention within the last 3 months
- Clinically significant valvular heart disease in the opinion of the Investigator
- History of cerebrovascular accident or transient ischemic attack within the last 3 months
- Presence or history of malignancy that required significant medical intervention within the preceding 3 months and/or is likely to result in death within the next 2 years
- Chronic renal impairment or renal insufficiency defined by a serum creatinine ³ 2.5 mEq/dL and/or the requirement for dialysis
- The subject is lactating, breastfeeding, or pregnant
- The subject has received any investigational medication within 30 days prior to the start of this study or be scheduled to receive another investigational drug during the course of this study
About this study
Cicletanine, which has been approved and launched for hypertension in France and Germany, has promise beyond hypertension in critically-unmet needs such as diabetes. It is evident from in vitro, animal and human studies that cicletanine's optimal dose in diabetes and other challenging, critically-unmet needs is likely to be higher than that for hypertension. Cicletanine's maximum tolerated dosage is not known, but the drug's dose-limiting effects are documented to be potassium loss and sodium loss from thiazide-type activity (one of the therapeutic mechanisms the drug is known to have); such thiazide-type losses are known to be reversed safely by magnesium. This trial explores the ability of magnesium to enhance cicletanine safety at higher doses in a trial involving patients with hypertension complicated by diabetes.
- Conditions
- Arterial Hypertension, Diabetes, Hypokalemia, Hyponatremia
- Being tested
- Cicletanine + magnesium, Cicletanine
- Keywords
- Cicletanine, Magnesium, Metabolic disease
- Medical subject headings
- Hypertension, Diabetes Mellitus, Hypokalemia, Hyponatremia, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cicletanine + magnesiumDrug
Cicletanine is an orally-dosed furopyridine drug launched or hypertension in France in 1988 (and soon thereafter in Germany by IPSEN. While the drug's maximum tolerated dose is not known, the principal concern (and so far only material concern) at higher doses is the decrease in levels of sodium and potassium. Trials so far have take n the drug up to 400 mg QD (once daily); it was well tolerated at that dose. The drug has had an excellent safety profile in its ~1.8 million patient-years of post-launch experience,
Magnesium is being added to cicletanine in order to decrease losses of potassium and sodium, thereby enhancing cicletanine's safety at higher doses.
CicletanineDrug
Cicletanine is an orally-dosed furopyridine drug launched or hypertension in France in 1988 (and soon thereafter in Germany by IPSEN. While the drug's maximum tolerated dose is not known, the principal concern (and so far only material concern) at higher doses is the decrease in levels of sodium and potassium. Trials so far have take n the drug up to 400 mg QD; it was well tolerated at that dose. The drug has had an excellent safety profile in its ~1.8 million patient-years of post-launch experience,
| Study group | Role | What they receive |
|---|---|---|
| Cicletanine | Active comparator | Patients will take escalating doses of cicletanine Receives: Drug: Cicletanine |
| Cicletanine + magnesium | Experimental | Patients will take escalating doses of cicletanine; patients will in addition take magnesium Receives: Drug: Cicletanine + magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to potassium rescue
The primary endpoint is the preservation of potassium levels at or above 3.3 mEq/L (milliequivalents per liter). A time to event model using the Log Rank test will be used to compare the Mg Group and those in the Non-Mg Group.
Measured: 13 weeks (duration of study)
Secondary outcomes (7)
Reduction in systolic blood pressure vs. baseline
Aggregate measure made for all 24 patients (12 cicletanine + magnesium; 12 cicletanine only). Subgroup analyses will also be made as feasible.
Measured: 13 weeks (duration of study)
Reduction in diastolic blood pressure vs. baseline
Aggregate measure made for all 24 patients (12 cicletanine + magnesium; 12 cicletanine only). Subgroup analyses will also be made as feasible.
Measured: 13 weeks (duration of study)
Reduction in HbA1c vs. baseline
Aggregate measure made for all 24 patients (12 cicletanine + magnesium; 12 cicletanine only). Subgroup analyses will also be made as feasible.
Measured: 13 weeks (duration of study)
CRP (C reactive protein) levels
CRP (C-reactive protein) is a measure of general inflammation.
This will be an aggregate measure made for all 24 patients (12 cicletanine + magnesium; 12 cicletanine only). Subgroup analyses will also be made as feasible.
Measured: 13 weeks (duration of study)
Average levels of potassium in patients on cicletanine with and without magnesium
The average potassium levels levels in the two groups (cicletanine + magnesium; cicletanine only) will be compared. Subgroup analyses will also be made as feasible.
Measured: 13 weeks (duration of study)
Average levels of sodium in patients on cicletanine with and without magnesium
The average sodium levels levels in the two groups (cicletanine + magnesium; cicletanine only) will be compared. Subgroup analyses will also be made as feasible.
Measured: 13 weeks (duration of study)
Average levels of magnesium in patients on cicletanine with and without magnesium
The average magnesium levels levels in the two groups (cicletanine + magnesium; cicletanine only) will be compared. Subgroup analyses will also be made as feasible.
Measured: 13 weeks (duration of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startJun 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navitas Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IndiPharm Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709031
- Sponsor's protocol ID
- NAV-011
- Acronym
- CHAMP
- Status last verified
- Aug 2021
- First submitted
- 10 Mar 2016
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cicletanine in Hypertension With Diabetes: Added Magnesium Preserves Potassium and Sodium
- ClinicalTrials.gov ID
- NCT02709031
- Acronym / sponsor ID
- CHAMP / NAV-011
- Conditions
- Arterial Hypertension, Diabetes, Hypokalemia, Hyponatremia
- Keywords
- Cicletanine, Magnesium, Metabolic disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Navitas PharmaIndustry (pharma, biotech, devices)
- Collaborators
- IndiPharm Inc.
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 15 Mar 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.
Cicletanine, which has been approved and launched for hypertension in France and Germany, has promise beyond hypertension in critically-unmet needs such as diabetes. It is evident from in vitro, animal and human studies that cicletanine's optimal dose in diabetes and other challenging, critically-unmet needs is likely to be higher than that for hypertension. Cicletanine's maximum tolerated dosage is not known, but the drug's dose-limiting effects are documented to be potassium loss and sodium loss from thiazide-type activity (one of the therapeutic mechanisms the drug is known to have); such thiazide-type losses are known to be reversed safely by magnesium. This trial explores the ability of magnesium to enhance cicletanine safety at higher doses in a trial involving patients with hypertension complicated by diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cicletanine | Active comparator | Drug: CicletaninePatients will take escalating doses of cicletanine |
| Cicletanine + magnesium | Experimental | Drug: Cicletanine + magnesiumPatients will take escalating doses of cicletanine; patients will in addition take magnesium |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sitting SBP (systolic blood pressure) > 150 mmHg (millimeters of mercury) after five minutes' rest.
- Type II diabetes, with HbA1c between 8.5 and 11.5%. If a patient at screening presents outside of this range, the investigator may elect to re-screen a patient once to determine further the patient's eligibility.
- Age >18 and < 80 years of age
- BMI between 20 and 35, inclusive
- Have been stable on existing therapy for at least 30 days prior to initiation of cicletanine (Visit 2)
Key exclusion criteria (15 listed)
- Use of potassium supplementation over the past 30 days
- Use of potassium-wasting diuretics, e. g., thiazides over the past 30 days
- AST (aspartate aminotransferase; also abbreviated SGOT) outside normal range of 5 and 40 mg/dL inclusive
- ALT (alanine aminotransferase; also abbreviated SGPT) outside normal range of 7 and 56 mg/dL inclusive
- Laboratory findings outside of normal range can be considered grounds for exclusion at the discretion of the Sponsor, Medical Monitor and / or Principal Investigator
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 |
|---|---|---|
| Cicletanine + magnesiumCicletanine is an orally-dosed furopyridine drug launched or hypertension in France in 1988 (and soon thereafter in Germany by IPSEN. While the drug's maximum tolerated dose is not known, the principal concern (and so far only material concern) at higher doses is the decrease in levels of sodium and potassium. Trials so far have take n the drug up to 400 mg QD (once daily); it was well tolerated at that dose. The drug has had an excellent safety profile in its ~1.8 million patient-years of post-launch experience, Magnesium is being added to cicletanine in order to decrease losses of potassium and sodium, thereby enhancing cicletanine's safety at higher doses. | Drug | Cicletanine + magnesium |
| CicletanineCicletanine is an orally-dosed furopyridine drug launched or hypertension in France in 1988 (and soon thereafter in Germany by IPSEN. While the drug's maximum tolerated dose is not known, the principal concern (and so far only material concern) at higher doses is the decrease in levels of sodium and potassium. Trials so far have take n the drug up to 400 mg QD; it was well tolerated at that dose. The drug has had an excellent safety profile in its ~1.8 million patient-years of post-launch experience, | Drug | Cicletanine |
Primary outcome
Time to potassium rescue
Time frame: 13 weeks (duration of study)
The primary endpoint is the preservation of potassium levels at or above 3.3 mEq/L (milliequivalents per liter). A time to event model using the Log Rank test will be used to compare the Mg Group and those in the Non-Mg Group.
7 secondary outcomes
Reduction in systolic blood pressure vs. baseline
Time frame: 13 weeks (duration of study)
Reduction in diastolic blood pressure vs. baseline
Time frame: 13 weeks (duration of study)
Reduction in HbA1c vs. baseline
Time frame: 13 weeks (duration of study)
CRP (C reactive protein) levels
Time frame: 13 weeks (duration of study)
Average levels of potassium in patients on cicletanine with and without magnesium
Time frame: 13 weeks (duration of study)
Average levels of sodium in patients on cicletanine with and without magnesium
Time frame: 13 weeks (duration of study)
Average levels of magnesium in patients on cicletanine with and without magnesium
Time frame: 13 weeks (duration of study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Arterial Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cicletanine + magnesium and Cicletanine in people with Arterial Hypertension and Diabetes, run by Navitas Pharma.
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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Results are not available in the source record.
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?
Time to potassium rescue (time frame: 13 weeks (duration of study)). 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 5 Sep 2021.