HypertensionPhase 1NCT00943852
The Effect of Losartan and Losartan Plus Isosorbide Mononitrate on Central Blood Pressure Measurements (0954-317)
A Phase 1 study testing losartan potassium, Comparator: isosorbide mononitrate (ISMN) and Comparator: losartan + ISMN in people with Hypertension, run by Organon and Co.
Trial summary
This study will qualify a functional model that can measure central blood pressure and vascular compliance effects through noninvasive means. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- losartan potassium, Comparator: isosorbide mononitrate (ISMN) and Comparator: losartan + ISMN
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Dec 2006
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is in good health with the exception of mild to moderate hypertension
- Patient is willing to comply with the study restrictions
- Patient does not smoke
Who cannot join
- Patient has a history of any illness that might confound the results of the study or make participation in the study unsafe
- Patient is taking a prescription medication that is contraindicated for use with COZAAR® or IMDUR®
- Patient has a condition for which there is a warning, contraindication, or precaution against the use of COZAAR® or IMDUR®
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, 5-Period Crossover Study to Evaluate the Effects of a Single Dose of Losartan, a Single Dose of Isosorbide Mononitrate (ISMN), and Single Doses of Losartan + ISMN on Central Blood Pressure Measurements in Mildly Hypertensive Patients
This study will qualify a functional model that can measure central blood pressure and vascular compliance effects through noninvasive means.
- Conditions
- Hypertension
- Being tested
- losartan potassium, Comparator: isosorbide mononitrate (ISMN), Comparator: losartan + ISMN, Comparator: Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
losartan potassiumDrug
Also called COZAAR
Single dose losartan 100 mg in one of five treatment periods
Comparator: isosorbide mononitrate (ISMN)Drug
Also called IMDUR
Single dose ISMN 60 mg in one of five treatment periods
Comparator: losartan + ISMNDrug
Single dose losartan 100 mg and ISMN 15 mg in one of five treatment periods
Comparator: losartan + ISMNDrug
Single dose losartan 100 mg and ISMN 60 mg in one of five treatment periods
Comparator: PlaceboDrug
Single dose placebo only in one of five treatment periods
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | losartan 100 mg Receives: Drug: losartan potassium |
| 2 | Active comparator | ISMN 60 mg Receives: Drug: Comparator: isosorbide mononitrate (ISMN) |
| 3 | Active comparator | losartan 100 mg + ISMN 15 mg Receives: Drug: Comparator: losartan + ISMN |
| 4 | Active comparator | losartan 100 mg + ISMN 60 mg Receives: Drug: Comparator: losartan + ISMN |
| 5 | Placebo comparator | Placebo Receives: Drug: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg Plus ISMN 60 mg Versus Single Dose of Losartan 100 mg
The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.
Measured: Baseline and 10 hours postdose
Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg + ISMN 60 mg Versus Single Dose of Placebo
The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P =
pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.
Measured: Baseline and 10 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startAug 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943852
- Sponsor's protocol ID
- 0954-317
- Other IDs
- MK0954-317, 2009_610
- Status last verified
- Feb 2022
- First submitted
- 21 Jul 2009
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Kaufman R, Nunes I, Bolognese JA, Miller DL, Salotti D, McCarthy JM, Smith WB, Herman GA, Feig PU. Single-dose effects of isosorbide mononitrate alone or in combination with losartan on central blood pressure. J Am Soc Hypertens. 2010 Nov-Dec;4(6):311-8. doi: 10.1016/j.jash.2010.10.004.
PubMed 21130977
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, 5-Period Crossover Study to Evaluate the Effects of a Single Dose of Losartan, a Single Dose of Isosorbide Mononitrate (ISMN), and Single Doses of Losartan + ISMN on Central Blood Pressure Measurements in Mildly Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00943852
- Acronym / sponsor ID
- 0954-317
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Posted 15 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will qualify a functional model that can measure central blood pressure and vascular compliance effects through noninvasive means.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: losartan potassiumlosartan 100 mg |
| 2 | Active comparator | Drug: Comparator: isosorbide mononitrate (ISMN)ISMN 60 mg |
| 3 | Active comparator | Drug: Comparator: losartan + ISMNlosartan 100 mg + ISMN 15 mg |
| 4 | Active comparator | Drug: Comparator: losartan + ISMNlosartan 100 mg + ISMN 60 mg |
| 5 | Placebo comparator | Drug: Comparator: PlaceboPlacebo |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is in good health with the exception of mild to moderate hypertension
- Patient is willing to comply with the study restrictions
- Patient does not smoke
Key exclusion criteria (3 listed)
- Patient has a history of any illness that might confound the results of the study or make participation in the study unsafe
- Patient is taking a prescription medication that is contraindicated for use with COZAAR® or IMDUR®
- Patient has a condition for which there is a warning, contraindication, or precaution against the use of COZAAR® or IMDUR®
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 |
|---|---|---|
| losartan potassiumAlso: COZAARSingle dose losartan 100 mg in one of five treatment periods | Drug | 1 |
| Comparator: isosorbide mononitrate (ISMN)Also: IMDURSingle dose ISMN 60 mg in one of five treatment periods | Drug | 2 |
| Comparator: losartan + ISMNSingle dose losartan 100 mg and ISMN 15 mg in one of five treatment periods | Drug | 3 |
| Comparator: losartan + ISMNSingle dose losartan 100 mg and ISMN 60 mg in one of five treatment periods | Drug | 4 |
| Comparator: PlaceboSingle dose placebo only in one of five treatment periods | Drug | 5 |
Primary outcome
Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg Plus ISMN 60 mg Versus Single Dose of Losartan 100 mg
Time frame: Baseline and 10 hours postdose
The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.
Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg + ISMN 60 mg Versus Single Dose of Placebo
Time frame: Baseline and 10 hours postdose
The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21130977Kaufman R, Nunes I, Bolognese JA, Miller DL, Salotti D, McCarthy JM, Smith WB, Herman GA, Feig PU. Single-dose effects of isosorbide mononitrate alone or in combination with losartan on central blood pressure. J Am Soc Hypertens. 2010 Nov-Dec;4(6):311-8. doi: 10.1016/j.jash.2010.10.004.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing losartan potassium, Comparator: isosorbide mononitrate (ISMN) and Comparator: losartan + ISMN in people with Hypertension, run by Organon and Co.
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 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: finished, as of the sponsor's last update on 9 Feb 2022. 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. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg Plus ISMN 60 mg Versus Single Dose of Losartan 100 mg (time frame: Baseline and 10 hours postdose). The study lists 2 primary outcomes in all. 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 NCT00943852, which also lists 1 linked publication.
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 9 Feb 2022.