Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008_580 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate methodologies for measuring pedal edema associated with calcium channel blockers in middle-aged and elderly subjects and patients with hypertension.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | amlodipine |
|
| 2 | Placebo Comparator | Placebo to amlodipine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: amlodipine besylate | Drug | Two 5 mg tablets amlodipine daily for 6 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2 | Least Squares Mean Difference from Baseline | Baseline and 2 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22385927 | Derived | 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. |
Not provided
Not provided
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)
Participants were recruited across 3 Phase I clinical research units in the US. Participants participated from July 2008 to March 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Amlodipine 10 Milligrams | Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks |
| FG001 | Placebo | Participants who were randomized to treatment with placebo once daily for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Amlodipine 10 Milligrams | Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks |
| BG001 | Placebo | Participants who were randomized to treatment with placebo once daily for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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). | Posted | Least Squares Mean | Standard Deviation | Ohms | Baseline and 2 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amlodipine 10 Milligrams | Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | clinicaltrialsdisclosure@merck.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparator: Placebo |
| Drug |
Two 5 mg tablets placebo to amlodipine daily for 6 weeks |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 |
| Placebo |
Participants who were randomized to treatment with placebo once daily for 6 weeks |
|
|
|
| Secondary | Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2 | Least Squares Mean Difference from Baseline | 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. | Posted | Least Squares Mean | Standard Deviation | Grams | Baseline and 2 weeks |
|
|
|
|
| 0 |
| 24 |
| 17 |
| 24 |
| EG001 | Placebo | Participants who were randomized to treatment with placebo once daily for 6 weeks | 0 | 23 | 16 | 23 |
| Myodesopsia | Eye disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Feeling Hot | General disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Inflammation | General disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
|
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Tension Headache | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Euphoric Mood | Psychiatric disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
|
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.