HypertensionPhase 1NCT00789321

A Study to Evaluate Methodologies for Measuring Swelling of the Leg and Ankle (MK-0000-106)(COMPLETED)

A Phase 1 study testing Comparator: amlodipine besylate in people with Hypertension, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will evaluate methodologies for measuring pedal edema associated with calcium channel blockers in middle-aged and elderly subjects and patients with hypertension. Read more about this study

Who is it for?: Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Hypertension
What is being tested?: Comparator: amlodipine besylate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: No sites listed yet
Study dates: Jul 2008to Mar 2009
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 50 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patient does not have hypertension or has Stage I or II hypertension and is taking < 3 anti-hypertension medications
Patient is willing to discontinue all anti-hypertensive medications during study
Patient is willing to refrain from drinking alcohol for 24 hours prior to each study visit and is willing to limit intake at other times during the study to 2 drinks per day
Patient agrees to avoid caffeine for 24 hours prior to each study visit. At other times during study, daily caffeine intake should not exceed 4 cups of coffee (or equivalent)
Patient will avoid strenuous physical activity during study
Patient is a nonsmoker or has not smoked for the last 3 months

Who cannot join

Patient has metal implants in the leg or artificial limbs
Patient has had a lower limb amputation, malformation, alterations in leg muscles, or a history of musculoskeletal disease
Patient has used oral contraceptive pills or hormone replacement therapy within 3 months of screening
Patient has a history of stroke or seizures
Patient has a history of cancer, except that which was treated at least 10 years prior to screening and shows no evidence of recurrence

About this study

Official title: A Randomized Clinical Trial to Evaluate the Effects of Multiple Doses of Amlodipine 10 mg on Pedal Edema Measurements in Middle-Aged and Elderly Healthy Subjects and Patient With Hypertension

This study will evaluate methodologies for measuring pedal edema associated with calcium channel blockers in middle-aged and elderly subjects and patients with hypertension.

Conditions: Hypertension
Being tested: Comparator: amlodipine besylate, 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.

Comparator: amlodipine besylateDrug
Two 5 mg tablets amlodipine daily for 6 weeks.
Comparator: PlaceboDrug
Two 5 mg tablets placebo to amlodipine daily for 6 weeks

Study groups in NCT00789321
Study group	Role	What they receive
1	Experimental	amlodipine Receives: Drug: Comparator: amlodipine besylate
2	Placebo comparator	Placebo to amlodipine Receives: Drug: Comparator: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2
Segmental biomimpedance was measured using a multifrequency analyzer (ImpediMed SFB7). The device was used to measure impedance (measured in Ohms) of a small current traveling between leads placed at the ankle and knee. Least Squares Mean Difference from Baseline in impedance is the primary endpoint.
Measured: Baseline and 2 weeks

Secondary outcomes (1)

Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2
Least Squares Mean Difference from Baseline
Measured: Baseline and 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Mar 2009

First posted11 Nov 2008 (estimated)
Study startJul 2008
Primary completionFeb 2009
Study completionMar 2009

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.
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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00789321
Sponsor's protocol ID: 0000-106
Other IDs: 2008_580
Status last verified: Aug 2015
First submitted: 10 Nov 2008
Last updated: 11 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Schoeller DA, Alon A, Manekas D, Mixson LA, Lasseter KC, Noonan GP, Bolognese JA, Heymsfield SB, Beals CR, Nunes I. Segmental bioimpedance for measuring amlodipine-induced pedal edema: a placebo-controlled study. Clin Ther. 2012 Mar;34(3):580-92. doi: 10.1016/j.clinthera.2012.01.018. Epub 2012 Mar 3.
PubMed 22385927

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Clinical Trial to Evaluate the Effects of Multiple Doses of Amlodipine 10 mg on Pedal Edema Measurements in Middle-Aged and Elderly Healthy Subjects and Patient With Hypertension
ClinicalTrials.gov ID: NCT00789321
Acronym / sponsor ID: 0000-106
Conditions: Hypertension
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Feb 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 11 Nov 2008 (estimated)
Results: Posted 8 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 evaluate methodologies for measuring pedal edema associated with calcium channel blockers in middle-aged and elderly subjects and patients with hypertension.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Comparator: amlodipine besylateamlodipine
2	Placebo comparator	Drug: Comparator: PlaceboPlacebo to amlodipine

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patient does not have hypertension or has Stage I or II hypertension and is taking < 3 anti-hypertension medications
Patient is willing to discontinue all anti-hypertensive medications during study
Patient is willing to refrain from drinking alcohol for 24 hours prior to each study visit and is willing to limit intake at other times during the study to 2 drinks per day
Patient agrees to avoid caffeine for 24 hours prior to each study visit. At other times during study, daily caffeine intake should not exceed 4 cups of coffee (or equivalent)
Patient will avoid strenuous physical activity during study

Key exclusion criteria (5 listed)

Patient has metal implants in the leg or artificial limbs
Patient has had a lower limb amputation, malformation, alterations in leg muscles, or a history of musculoskeletal disease
Patient has used oral contraceptive pills or hormone replacement therapy within 3 months of screening
Patient has a history of stroke or seizures
Patient has a history of cancer, except that which was treated at least 10 years prior to screening and shows no evidence of recurrence

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
Comparator: amlodipine besylateTwo 5 mg tablets amlodipine daily for 6 weeks.	Drug	1
Comparator: PlaceboTwo 5 mg tablets placebo to amlodipine daily for 6 weeks	Drug	2

Primary outcome

Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2
Time frame: Baseline and 2 weeks
Segmental biomimpedance was measured using a multifrequency analyzer (ImpediMed SFB7). The device was used to measure impedance (measured in Ohms) of a small current traveling between leads placed at the ankle and knee. Least Squares Mean Difference from Baseline in impedance is the primary endpoint.

1 secondary outcome

Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2
Time frame: Baseline and 2 weeks

Results and safety

Results posted to the registry on 8 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Amlodipine 10 Milligrams	24	24
Placebo	23	22

Primary outcome: Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2

Time frame: Baseline and 2 weeks. Least squares mean (Standard Deviation). Unit: Ohms

Measure	Amlodipine 10 Milligrams n = 24	Placebo n = 22
Value	-7.9 (20.7)	3.8 (17.0)

Amlodipine 10 Milligrams vs Placebo: Least Squares Mean: -11.7 (90% CI -18.1 to -5.4), p = 0.001, ANCOVA

Population analysed: All patients treated with segmental bioimpedance measurements at baseline and 2 weeks - one patient in the placebo group was not included (dropped out of study due to viral infection prior to Week 2).

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Amlodipine 10 Milligrams	0 of 24 (0%)	17 of 24 (70.8%)	Not reported
Placebo	0 of 23 (0%)	16 of 23 (69.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22385927Schoeller DA, Alon A, Manekas D, Mixson LA, Lasseter KC, Noonan GP, Bolognese JA, Heymsfield SB, Beals CR, Nunes I. Segmental bioimpedance for measuring amlodipine-induced pedal edema: a placebo-controlled study. Clin Ther. 2012 Mar;34(3):580-92. doi: 10.1016/j.clinthera.2012.01.018. Epub 2012 Mar 3.

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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 Comparator: amlodipine besylate 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 11 Aug 2015. 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 8 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?

Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2 (time frame: Baseline and 2 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 NCT00789321, 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 11 Aug 2015.