Trial Outcomes & Findings for Assessment of Aliskiren/Amlodipine and Amlodipine on Ankle Foot Volume (AFV) in Patients With Hypertension (NCT NCT01080768)
NCT ID: NCT01080768
Last Updated: 2011-12-26
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Baseline, 4 weeks
Results posted on
2011-12-26
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
17
|
|
Overall Study
COMPLETED
|
12
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Deviation
|
2
|
1
|
Baseline Characteristics
Assessment of Aliskiren/Amlodipine and Amlodipine on Ankle Foot Volume (AFV) in Patients With Hypertension
Baseline characteristics by cohort
| Measure |
Aliskiren/Amlodipine + Placebo to Amlodipine
n=14 Participants
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.
|
Amlodipine+ Placebo to Aliskiren/Amlodipine
n=17 Participants
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.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
55.4 years
STANDARD_DEVIATION 6.21 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 4.49 • n=7 Participants
|
56.8 years
STANDARD_DEVIATION 5.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Aliskiren/Amlodipine and Placebo to Amlodipine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Amlodipine and Placebo to Aliskiren/Amlodipine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aliskiren/Amlodipine and Placebo to Amlodipine
n=14 participants at risk
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 patient 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.
|
Amlodipine and Placebo to Aliskiren/Amlodipine
n=17 participants at risk
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 patient 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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14
|
0.00%
0/17
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/14
|
5.9%
1/17
|
|
General disorders
Chest discomfort
|
0.00%
0/14
|
5.9%
1/17
|
|
General disorders
Oedema peripheral
|
0.00%
0/14
|
5.9%
1/17
|
|
Infections and infestations
Otitis externa
|
7.1%
1/14
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14
|
5.9%
1/17
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14
|
0.00%
0/17
|
|
Nervous system disorders
Headache
|
7.1%
1/14
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/14
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.1%
1/14
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
1/14
|
0.00%
0/17
|
|
Cardiac disorders
Palpitations
|
7.1%
1/14
|
0.00%
0/17
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER