HypertensionPhase 1NCT00856960
The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males (MK-0000-127)
A Phase 1 study testing Aliskiren and Comparator: Losartan in people with Hypertension, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate the effect of Aliskiren and Losartan on renal blood flow using PAH clearance, PC MRA and ASL MRI methodologies. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Aliskiren and Comparator: Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Apr 2010
- Phase
- Phase 1
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is in generally good health
- Subject is willing to avoid unaccustomed strenuous exercise during the study
- Subject agrees to consume ONLY the study-specified diet during all domiciled periods
- Subject has been a non-smoker for at least 3 months prior to study
- Subject will refrain from smoking or using any tobacco products during the study
- Subject agrees to refrain from consuming alcohol or caffeine during the domiciled periods and agrees to limit alcohol and caffeine consumption throughout the study
Who cannot join
- Subject has contraindication to MRI scans
- Subject has a history of stroke, seizure, or major neurological disorders
- Subject uses illicit drugs or has a history of drug/alcohol abuse
- Subject has had major surgery, has donated or lost 1 unit of blood, or has been in another investigational study in the last 4 weeks
- Subject has a history of multiple and/or severe allergies to drugs or food
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, 4-Treatment, 3-Period, Incomplete Block, Balanced Crossover Study to Evaluate the Effects of a Single Dose of Aliskiren and Losartan on Renal Blood Flow Measurements in Healthy Male Subjects
This study will evaluate the effect of Aliskiren and Losartan on renal blood flow using PAH clearance, PC MRA and ASL MRI methodologies.
- Conditions
- Hypertension
- Being tested
- Aliskiren, Comparator: Losartan, Comparator: Placebo to Aliskiren, Comparator: Placebo to Losartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
Single dose of four 150 mg tablets (600 mg total) Aliskiren in one of three study periods. There will be at least 10 days between each study period.
AliskirenDrug
Single dose of one 150 mg tablet of Aliskiren in one of three study periods. There will be at least 10 days between each study period.
Comparator: LosartanDrug
Single dose of one 100 mg tablet Losartan in one of three study periods. There will be at least 10 days between each study period.
Comparator: Placebo to AliskirenDrug
Three or four tablets placebo to Aliskiren 150 mg in one of three study periods. There will be at least 10 days between each study period.
Comparator: Placebo to LosartanDrug
Single dose of placebo to Losartan 100 mg in one of three study periods. There will be at least 10 days between each study period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Aliskiren 600 mg Receives: Drug: Aliskiren; Drug: Comparator: Placebo to Losartan |
| 2 | Active comparator | Aliskiren 150 mg Receives: Drug: Aliskiren; Drug: Comparator: Placebo to Aliskiren; Drug: Comparator: Placebo to Losartan |
| 3 | Active comparator | Losartan 100 mg Receives: Drug: Comparator: Losartan; Drug: Comparator: Placebo to Aliskiren |
| 4 | Placebo comparator | Placebo Receives: Drug: Comparator: Placebo to Aliskiren; Drug: Comparator: Placebo to Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren
Measured: 2-5 hours post dose of study drug
Secondary outcomes (1)
change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Losartan
Measured: 2-5 hours post dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionApr 2010
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 Merck Sharp & Dohme LLCThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- 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
- NCT00856960
- Sponsor's protocol ID
- 0000-127
- Other IDs
- 127, 2009_554
- Status last verified
- Jan 2016
- First submitted
- 27 Feb 2009
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, 4-Treatment, 3-Period, Incomplete Block, Balanced Crossover Study to Evaluate the Effects of a Single Dose of Aliskiren and Losartan on Renal Blood Flow Measurements in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00856960
- Acronym / sponsor ID
- 0000-127
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 6 Mar 2009 (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.
This study will evaluate the effect of Aliskiren and Losartan on renal blood flow using PAH clearance, PC MRA and ASL MRI methodologies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Aliskiren, Drug: Comparator: Placebo to LosartanAliskiren 600 mg |
| 2 | Active comparator | Drug: Aliskiren, Drug: Comparator: Placebo to Aliskiren, Drug: Comparator: Placebo to LosartanAliskiren 150 mg |
| 3 | Active comparator | Drug: Comparator: Losartan, Drug: Comparator: Placebo to AliskirenLosartan 100 mg |
| 4 | Placebo comparator | Drug: Comparator: Placebo to Aliskiren, Drug: Comparator: Placebo to LosartanPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject is in generally good health
- Subject is willing to avoid unaccustomed strenuous exercise during the study
- Subject agrees to consume ONLY the study-specified diet during all domiciled periods
- Subject has been a non-smoker for at least 3 months prior to study
- Subject will refrain from smoking or using any tobacco products during the study
Key exclusion criteria (5 listed)
- Subject has contraindication to MRI scans
- Subject has a history of stroke, seizure, or major neurological disorders
- Subject uses illicit drugs or has a history of drug/alcohol abuse
- Subject has had major surgery, has donated or lost 1 unit of blood, or has been in another investigational study in the last 4 weeks
- Subject has a history of multiple and/or severe allergies to drugs or food
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 |
|---|---|---|
| AliskirenSingle dose of four 150 mg tablets (600 mg total) Aliskiren in one of three study periods. There will be at least 10 days between each study period. | Drug | 1 |
| AliskirenSingle dose of one 150 mg tablet of Aliskiren in one of three study periods. There will be at least 10 days between each study period. | Drug | 2 |
| Comparator: LosartanSingle dose of one 100 mg tablet Losartan in one of three study periods. There will be at least 10 days between each study period. | Drug | 3 |
| Comparator: Placebo to AliskirenThree or four tablets placebo to Aliskiren 150 mg in one of three study periods. There will be at least 10 days between each study period. | Drug | 2, 3, 4 |
| Comparator: Placebo to LosartanSingle dose of placebo to Losartan 100 mg in one of three study periods. There will be at least 10 days between each study period. | Drug | 1, 2, 4 |
Primary outcome
change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren
Time frame: 2-5 hours post dose of study drug
1 secondary outcome
change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Losartan
Time frame: 2-5 hours post dose of study drug
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 22 Jan 2016.
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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 Aliskiren and Comparator: Losartan in people with Hypertension, run by Merck Sharp & Dohme LLC.
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 6 inclusion and 5 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 22 Jan 2016. 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?
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?
change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren (time frame: 2-5 hours post dose of study drug). 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 22 Jan 2016.