Hypertension, Ankle Edema
Conditions
Keywords
Pedal edema, hypertension, aliskiren, amlodipine
Brief summary
The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.
Interventions
Aliskiren/amlodipine 150/5 mg/day
DRUGAmlodipine
Amlodipine 5 mg/day.
Placebo to Aliskiren/amlodipine 150/10 mg/day
DRUGPlacebo to Amlodipine
Placebo to Amlodipine 5 mg/day
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients (male or female) with hypertension aged between 18-75 yrs. * Patients not treated with amlodipine or no amlodipine in previous 1 year. * Post-menopausal females
Exclusion criteria
* Patients unable to switch from prior hypertensive medication. * Severe hypertension. * Pregnant or nursing females. * Patients with Type 1 or Type 2 diabetes mellitus * History of immunodeficiency diseases, including a positive Human immunodeficiency virus (HIV) (Enzyme-linked immunosorbent assay \[ELISA\] and Western blot) test result. * A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method | Baseline, 4 weeks | AFV (mL) was measured using the principle of water displacement using a commercially available foot volumeter. The amount of water displaced in milliliters (mL) equals the volume of the foot/ankle. The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aliskiren/Amlodipine + Placebo to Amlodipine During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day. | 14 |
| Amlodipine+ Placebo to Aliskiren/Amlodipine During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.
The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day. | 17 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Deviation | 2 | 1 |
Baseline characteristics
| Characteristic | Aliskiren/Amlodipine + Placebo to Amlodipine | Amlodipine+ Placebo to Aliskiren/Amlodipine | Total |
|---|---|---|---|
| Age Continuous | 55.4 years STANDARD_DEVIATION 6.21 | 58.0 years STANDARD_DEVIATION 4.49 | 56.8 years STANDARD_DEVIATION 5.4 |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 9 Participants | 13 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 14 | 2 / 17 |
| serious Total, serious adverse events | 0 / 14 | 0 / 17 |
Outcome results
Primary
Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method
AFV (mL) was measured using the principle of water displacement using a commercially available foot volumeter. The amount of water displaced in milliliters (mL) equals the volume of the foot/ankle. The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.
Time frame: Baseline, 4 weeks
Population: The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.