Blood PressurePhase 4NCT01029223
The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals
A Phase 4 study testing ivabradine and metoprolol in people with Blood Pressure, run by Bayside Health.
Trial summary
The purpose of this study is to determine the effect of slowing heart rate upon both central and peripheral blood pressures using a medication called Ivabradine which slows heart rate without affecting heart contraction, and to compare the effects of ivabradine to a traditional blood pressure lowering medication… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Blood Pressure
- What is being tested?
- ivabradine and metoprolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Dec 2011
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 - 25 years OR
- Aged > 60 years
Who cannot join
- Chronic disease
- Unable to give informed consent
- Treated or untreated systemic arterial hypertension (SBP > 160 mmHg and/or DBP > 90 mmHg)
- Resting bradycardia (heart rate < 60 beats/minute)
- Pregnancy or active lactation
About this study
The purpose of this study is to determine the effect of slowing heart rate upon both central and peripheral blood pressures using a medication called Ivabradine which slows heart rate without affecting heart contraction, and to compare the effects of ivabradine to a traditional blood pressure lowering medication called metoprolol (which is a beta-blocker).
- Conditions
- Blood Pressure
- Being tested
- ivabradine, metoprolol, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivabradineDrug
metoprololDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| ivabradine | Experimental | Not described Receives: Drug: ivabradine |
| metoprolol | Experimental | Not described Receives: Drug: metoprolol |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
central and peripheral arterial and pulse wave velocity
Measured: baseline, and 4 hours following the administration of placebo, metoprolol or ivabradine.
Secondary outcomes (1)
Central pulse pressure
Measured: Baseline measurements of central and peripheral arterial and pulse wave velocity will be made at baseline, and 4 hours following the administration of either placebo, metoprolol or ivabradine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029223
- Sponsor's protocol ID
- 141/07
- Status last verified
- Nov 2011
- First submitted
- 7 Dec 2009
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals
- ClinicalTrials.gov ID
- NCT01029223
- Acronym / sponsor ID
- 141/07
- Conditions
- Blood Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Bayside HealthOther government
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 9 Dec 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.
The purpose of this study is to determine the effect of slowing heart rate upon both central and peripheral blood pressures using a medication called Ivabradine which slows heart rate without affecting heart contraction, and to compare the effects of ivabradine to a traditional blood pressure lowering medication called metoprolol (which is a beta-blocker).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ivabradine | Experimental | Drug: ivabradine |
| metoprolol | Experimental | Drug: metoprolol |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 - 25 years OR
- Aged > 60 years
Key exclusion criteria (5 listed)
- Chronic disease
- Unable to give informed consent
- Treated or untreated systemic arterial hypertension (SBP > 160 mmHg and/or DBP > 90 mmHg)
- Resting bradycardia (heart rate < 60 beats/minute)
- Pregnancy or active lactation
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 |
|---|---|---|
| ivabradine | Drug | ivabradine |
| metoprolol | Drug | metoprolol |
| placebo | Drug | placebo |
Primary outcome
central and peripheral arterial and pulse wave velocity
Time frame: baseline, and 4 hours following the administration of placebo, metoprolol or ivabradine.
1 secondary outcome
Central pulse pressure
Time frame: Baseline measurements of central and peripheral arterial and pulse wave velocity will be made at baseline, and 4 hours following the administration of either placebo, metoprolol or ivabradine.
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 9 Nov 2011.
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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.
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 4 study testing ivabradine and metoprolol in people with Blood Pressure, run by Bayside Health.
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 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: withdrawn, as of the sponsor's last update on 9 Nov 2011. 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 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?
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?
central and peripheral arterial and pulse wave velocity (time frame: baseline, and 4 hours following the administration of placebo, metoprolol or ivabradine.). 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 9 Nov 2011.