Trial Outcomes & Findings for A Study to Evaluate Methodologies for Measuring Swelling of the Leg and Ankle (MK-0000-106)(COMPLETED) (NCT NCT00789321)
NCT ID: NCT00789321
Last Updated: 2015-08-11
Results Overview
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.
COMPLETED
PHASE1
47 participants
Baseline and 2 weeks
2015-08-11
Participant Flow
Participants were recruited across 3 Phase I clinical research units in the US. Participants participated from July 2008 to March 2009.
Participants taking anti-hypertensive medications at screening were required to washout of this therapy before randomization and remain off the therapy during the study. Participants were eligible if systolic blood pressure (BP) was ≥120 to \<180 mm Hg and diastolic BP was ≥80 to \<110 mm Hg at screening (or after 2-4 weeks of washout, if applicable)
Participant milestones
| Measure |
Amlodipine 10 Milligrams
Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
|
Placebo
Participants who were randomized to treatment with placebo once daily for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
|
Overall Study
COMPLETED
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Amlodipine 10 Milligrams
Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
|
Placebo
Participants who were randomized to treatment with placebo once daily for 6 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate Methodologies for Measuring Swelling of the Leg and Ankle (MK-0000-106)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Amlodipine 10 Milligrams
n=24 Participants
Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
|
Placebo
n=23 Participants
Participants who were randomized to treatment with placebo once daily for 6 weeks
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
59.0 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Body Mass Index
|
28.2 kg/m^2
STANDARD_DEVIATION 2.9 • n=5 Participants
|
29.0 kg/m^2
STANDARD_DEVIATION 2.7 • n=7 Participants
|
28.6 kg/m^2
STANDARD_DEVIATION 2.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Amlodipine 10 Milligrams
n=24 Participants
Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
|
Placebo
n=22 Participants
Participants who were randomized to treatment with placebo once daily for 6 weeks
|
|---|---|---|
|
Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2
|
-7.9 Ohms
Standard Deviation 20.7
|
3.8 Ohms
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksPopulation: All patients treated with water displacement 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) - two patients in the amlodipine group were excluded due to technical/procedural errors.
Least Squares Mean Difference from Baseline
Outcome measures
| Measure |
Amlodipine 10 Milligrams
n=22 Participants
Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
|
Placebo
n=22 Participants
Participants who were randomized to treatment with placebo once daily for 6 weeks
|
|---|---|---|
|
Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2
|
44.8 Grams
Standard Deviation 64.8
|
5.8 Grams
Standard Deviation 53.2
|
Adverse Events
Amlodipine 10 Milligrams
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amlodipine 10 Milligrams
n=24 participants at risk
Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
|
Placebo
n=23 participants at risk
Participants who were randomized to treatment with placebo once daily for 6 weeks
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
4.2%
1/24
|
0.00%
0/23
|
|
Eye disorders
Myodesopsia
|
4.2%
1/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Dry Mouth
|
4.2%
1/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24
|
4.3%
1/23
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24
|
4.3%
1/23
|
|
General disorders
Feeling Hot
|
4.2%
1/24
|
0.00%
0/23
|
|
General disorders
Inflammation
|
0.00%
0/24
|
4.3%
1/23
|
|
General disorders
Oedema Peripheral
|
50.0%
12/24
|
39.1%
9/23
|
|
General disorders
Pyrexia
|
4.2%
1/24
|
0.00%
0/23
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.2%
1/24
|
0.00%
0/23
|
|
Infections and infestations
Viral Infection
|
0.00%
0/24
|
4.3%
1/23
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
12.5%
3/24
|
8.7%
2/23
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
4.2%
1/24
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
4.2%
1/24
|
4.3%
1/23
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
4.2%
1/24
|
0.00%
0/23
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24
|
0.00%
0/23
|
|
Nervous system disorders
Headache
|
0.00%
0/24
|
4.3%
1/23
|
|
Nervous system disorders
Tension Headache
|
4.2%
1/24
|
8.7%
2/23
|
|
Psychiatric disorders
Euphoric Mood
|
4.2%
1/24
|
0.00%
0/23
|
|
Renal and urinary disorders
Polyuria
|
4.2%
1/24
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
4.2%
1/24
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.2%
1/24
|
0.00%
0/23
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER