Angina PectorisPhase 4NCT03777605
Absorption and Pharmacokinetics of Nitroglycerin to a New Formulation
A Phase 4 study testing Nitroglycerin 0.4 MG in people with Angina Pectoris, run by Kolding Sygehus at 1 site in Denmark.
Trial summary
The study evaluate the absorption rate of different sublingual formulation of nitroglycerine (NTG) either in the form of available tablets or a new rapid absorbable gelation capsule formulation "NTG1523" by determining T-max and area under the response curve of nitoglycerine in blood concentration as well as from… Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Nitroglycerin 0.4 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Dec 2018to 23 Dec 2020
- Phase
- Phase 4
- 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 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy volunteers
- Must be able to swallow tablets
Who cannot join
- Insulin dependent diabetes
- Thyroid disease
- any medial treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Absorption and Pharmacokinetics of Nitroglycerin as a Tablet or in the Form of Rapidly Degradable Capsule in Young Healthy
The study evaluate the absorption rate of different sublingual formulation of nitroglycerine (NTG) either in the form of available tablets or a new rapid absorbable gelation capsule formulation "NTG1523" by determining T-max and area under the response curve of nitoglycerine in blood concentration as well as from clinical effects after intake. Data is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: "The applicant's rights in a biomedical research project
Read the detailed description
Ten healthy young volunteers are recruited,, and the experiments begin at 07:45 after an overneight fast. BMI and blod pressure are recorded and a catheter is inserted in an anticubical vein for blood samples.
At 08.00 a sublingual tablet (Takeda, nitroglycerin 0.4 milligrams) tablet or a "NTG1523" capsule with 0.4 milligrams of nitroglycerine is placed under the tongue in random order. Subsequently, blood samples are taken every minute for 10 minutes, then every 10 minutes the following two hours. In addition, blood pressure and puls rate are measured every second minute the first ten minutes, and then every 10 minutes.Side effects and time to the participants registrate any effect of the drugs are assessed in a prefabricated scheme.
The disadvantages associated with the experiment are sought monitored by adverse event registration which ends at the end of the trial. The trial day lasts 2 hours in which blood samples are taken as described above, and blood pressure and records are stored .
- Conditions
- Angina Pectoris
- Being tested
- Nitroglycerin 0.4 MG
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitroglycerin 0.4 MGDrug
Also called "NTG1523"
The study evaluate absorption rate of nitroglycerine 0.4 milligrams as tablets or a quickly absorbable capsuel "NTG1523" determined by T-max and area under the response curve in the blood of NTG as well as from clinical effects.
Data is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: "The applicant's rights in a biomedical research project
| Study group | Role | What they receive |
|---|---|---|
| "NTG1523", rapid absorbable capsule | Experimental | Nitroglycerine 0.4 milligram taken as ordinary tablets or "NTG1523" rapid absorbable capsule once in the morning, and subsequently blood samples and observations for 2 hours are performed Receives: Drug: Nitroglycerin 0.4 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration of Nitroglycerine as a tablet or in the form of rapidly degradable capsule "NTG1523" in young healthy controls
Peak Plasma Concentration (Cmax)(ng(ml) of nitroglycerine
Measured: From 2 weeks up til 5 weeks
Secondary outcomes (2)
Blood pressure in response to Nitroglycerine
Blood pressure (mmHg)
Measured: From 2 weeks up til 5 weeks
Puls rate in response to Nitroglycerine
puls rate (beat/min)
Measured: From 2 weeks up til 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start23 Dec 2018 (estimated)
- Primary completion5 Dec 2020 (estimated)
- Study completion23 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A randomized, cross over design
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kolding Sygehus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ole Winther Rasmussen, Kolding Sygehus
- Investigators
- ole W Rasmussen, M.D. Dr.Sci, Principal investigator, Medical Dept.,Kolding Hospital, SLB, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777605
- Sponsor's protocol ID
- Nitroglycerine1523 (NTG1523)
- Status last verified
- Dec 2018
- First submitted
- 3 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nakashima E, Rigod JF, Lin ET, Benet LZ. Pharmacokinetics of nitroglycerin and its dinitrate metabolites over a thirtyfold range of oral doses. Clin Pharmacol Ther. 1990 May;47(5):592-8. doi: 10.1038/clpt.1990.80.
PubMed 2111749McAllister A, Mosberg H, Settlage JA, Steiner JA. Plasma levels of nitroglycerin generated by three nitroglycerin patch preparations, Nitradisc, Transiderm-Nitro and Nitro-Dur and one ointment formulation, Nitrobid. Br J Clin Pharmacol. 1986 Apr;21(4):365-9. doi: 10.1111/j.1365-2125.1986.tb05208.x.
PubMed 3085698
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption and Pharmacokinetics of Nitroglycerin as a Tablet or in the Form of Rapidly Degradable Capsule in Young Healthy
- ClinicalTrials.gov ID
- NCT03777605
- Acronym / sponsor ID
- Nitroglycerine1523 (NTG1523)
- Conditions
- Angina Pectoris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kolding SygehusUniversity, hospital or other
- Study start
- 23 Dec 2018 (estimated)
- Primary completion
- 5 Dec 2020 (estimated)
- Study completion
- 23 Dec 2020 (estimated)
- First posted
- 17 Dec 2018 (actual)
- 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 study evaluate the absorption rate of different sublingual formulation of nitroglycerine (NTG) either in the form of available tablets or a new rapid absorbable gelation capsule formulation "NTG1523" by determining T-max and area under the response curve of nitoglycerine in blood concentration as well as from clinical effects after intake. Data is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: "The applicant's rights in a biomedical research project
Detailed description
Ten healthy young volunteers are recruited,, and the experiments begin at 07:45 after an overneight fast. BMI and blod pressure are recorded and a catheter is inserted in an anticubical vein for blood samples.
At 08.00 a sublingual tablet (Takeda, nitroglycerin 0.4 milligrams) tablet or a "NTG1523" capsule with 0.4 milligrams of nitroglycerine is placed under the tongue in random order. Subsequently, blood samples are taken every minute for 10 minutes, then every 10 minutes the following two hours. In addition, blood pressure and puls rate are measured every second minute the first ten minutes, and then every 10 minutes.Side effects and time to the participants registrate any effect of the drugs are assessed in a prefabricated scheme.
The disadvantages associated with the experiment are sought monitored by adverse event registration which ends at the end of the trial. The trial day lasts 2 hours in which blood samples are taken as described above, and blood pressure and records are stored .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A randomized, cross over design
| Arm | Type | Receives |
|---|---|---|
| "NTG1523", rapid absorbable capsule | Experimental | Drug: Nitroglycerin 0.4 MGNitroglycerine 0.4 milligram taken as ordinary tablets or "NTG1523" rapid absorbable capsule once in the morning, and subsequently blood samples and observations for 2 hours are performed |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal healthy volunteers
- Must be able to swallow tablets
Key exclusion criteria (3 listed)
- Insulin dependent diabetes
- Thyroid disease
- any medial treatment
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 |
|---|---|---|
| Nitroglycerin 0.4 MGAlso: "NTG1523"The study evaluate absorption rate of nitroglycerine 0.4 milligrams as tablets or a quickly absorbable capsuel "NTG1523" determined by T-max and area under the response curve in the blood of NTG as well as from clinical effects. Data is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: "The applicant's rights in a biomedical research project | Drug | "NTG1523", rapid absorbable capsule |
Primary outcome
Peak Plasma Concentration of Nitroglycerine as a tablet or in the form of rapidly degradable capsule "NTG1523" in young healthy controls
Time frame: From 2 weeks up til 5 weeks
Peak Plasma Concentration (Cmax)(ng(ml) of nitroglycerine
2 secondary outcomes
Blood pressure in response to Nitroglycerine
Time frame: From 2 weeks up til 5 weeks
Puls rate in response to Nitroglycerine
Time frame: From 2 weeks up til 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Background: PubMed 2111749Nakashima E, Rigod JF, Lin ET, Benet LZ. Pharmacokinetics of nitroglycerin and its dinitrate metabolites over a thirtyfold range of oral doses. Clin Pharmacol Ther. 1990 May;47(5):592-8. doi: 10.1038/clpt.1990.80.
- Results publication: PubMed 3085698McAllister A, Mosberg H, Settlage JA, Steiner JA. Plasma levels of nitroglycerin generated by three nitroglycerin patch preparations, Nitradisc, Transiderm-Nitro and Nitro-Dur and one ointment formulation, Nitrobid. Br J Clin Pharmacol. 1986 Apr;21(4):365-9. doi: 10.1111/j.1365-2125.1986.tb05208.x.
- 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.
ole W Rasmussen, M.D. Dr.Sci principal investigator
Medical Dept.,Kolding Hospital, SLB, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitroglycerin 0.4 MG in people with Angina Pectoris, run by Kolding Sygehus at 1 site 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 3 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 19 Dec 2018. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact ole W Rasmussen, M.D., Dr.Sci (+4550506930, olew.rasmussen@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration of Nitroglycerine as a tablet or in the form of rapidly degradable capsule "NTG1523" in young healthy controls (time frame: From 2 weeks up til 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03777605, which also lists 2 linked publications.
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 19 Dec 2018.