Trial Outcomes & Findings for Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema (NCT NCT00768040)
NCT ID: NCT00768040
Last Updated: 2012-03-06
Results Overview
The central retinal thickness was measured by Optical coherence tomography (OCT). The changes in central retinal thickness (CRT) from baseline to the end of study at week 12 were analyzed using a univariate analysis of covariance model (ANCOVA) with baseline value as a covariate and treatment as a fixed factor
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Baseline to week 12
Results posted on
2012-03-06
Participant Flow
Participant milestones
| Measure |
Aliskiren 300 mg
Aliskiren 300 mg once daily for 12 weeks
|
Placebo
Matching placebo once daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Aliskiren 300 mg
Aliskiren 300 mg once daily for 12 weeks
|
Placebo
Matching placebo once daily for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Abnormal laboratory value
|
1
|
1
|
Baseline Characteristics
Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Aliskiren 300 mg
n=20 Participants
Aliskiren 300 mg once daily for 12 weeks
|
Placebo
n=19 Participants
Matching placebo once daily for 12 weeks
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
64.3 years
STANDARD_DEVIATION 10.76 • n=39 Participants
|
60.1 years
STANDARD_DEVIATION 10.57 • n=41 Participants
|
62.2 years
STANDARD_DEVIATION 10.74 • n=35 Participants
|
|
Age, Customized
18 - 64 years
|
9 participants
n=39 Participants
|
13 participants
n=41 Participants
|
22 participants
n=35 Participants
|
|
Age, Customized
65 - 84 years
|
11 participants
n=39 Participants
|
6 participants
n=41 Participants
|
17 participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 12Population: This study was terminated early due to low recruitment of patients.
The central retinal thickness was measured by Optical coherence tomography (OCT). The changes in central retinal thickness (CRT) from baseline to the end of study at week 12 were analyzed using a univariate analysis of covariance model (ANCOVA) with baseline value as a covariate and treatment as a fixed factor
Outcome measures
Outcome data not reported
Adverse Events
Aliskiren 300mg
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aliskiren 300mg
n=20 participants at risk
Aliskiren 300 mg once daily for 12 weeks
|
Placebo
n=19 participants at risk
Matching placebo once daily for 12 weeks
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
5.0%
1/20
|
0.00%
0/19
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20
|
0.00%
0/19
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/20
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Diabetic foot
|
5.0%
1/20
|
0.00%
0/19
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/20
|
5.3%
1/19
|
Other adverse events
| Measure |
Aliskiren 300mg
n=20 participants at risk
Aliskiren 300 mg once daily for 12 weeks
|
Placebo
n=19 participants at risk
Matching placebo once daily for 12 weeks
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/20
|
5.3%
1/19
|
|
Cardiac disorders
Palpitations
|
0.00%
0/20
|
5.3%
1/19
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/20
|
5.3%
1/19
|
|
Eye disorders
Choroidal neovascularisation
|
5.0%
1/20
|
0.00%
0/19
|
|
Eye disorders
Foreign body sensation in eyes
|
5.0%
1/20
|
0.00%
0/19
|
|
Eye disorders
Hyalosis asteroid
|
5.0%
1/20
|
0.00%
0/19
|
|
Eye disorders
Macular oedema
|
5.0%
1/20
|
5.3%
1/19
|
|
Eye disorders
Retinal exudates
|
0.00%
0/20
|
5.3%
1/19
|
|
Eye disorders
Retinal neovascularisation
|
5.0%
1/20
|
0.00%
0/19
|
|
Eye disorders
Vision blurred
|
5.0%
1/20
|
0.00%
0/19
|
|
Eye disorders
Vitreous detachment
|
5.0%
1/20
|
0.00%
0/19
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20
|
5.3%
1/19
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20
|
0.00%
0/19
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20
|
0.00%
0/19
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/20
|
5.3%
1/19
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20
|
10.5%
2/19
|
|
General disorders
Fatigue
|
5.0%
1/20
|
0.00%
0/19
|
|
General disorders
Pyrexia
|
0.00%
0/20
|
5.3%
1/19
|
|
Immune system disorders
Seasonal allergy
|
5.0%
1/20
|
5.3%
1/19
|
|
Infections and infestations
Folliculitis
|
0.00%
0/20
|
5.3%
1/19
|
|
Infections and infestations
Fungal skin infection
|
5.0%
1/20
|
0.00%
0/19
|
|
Infections and infestations
Gastroenteritis viral
|
5.0%
1/20
|
5.3%
1/19
|
|
Infections and infestations
Respiratory tract infection
|
5.0%
1/20
|
0.00%
0/19
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20
|
0.00%
0/19
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
5.0%
1/20
|
0.00%
0/19
|
|
Investigations
Blood pressure increased
|
0.00%
0/20
|
5.3%
1/19
|
|
Investigations
Weight decreased
|
0.00%
0/20
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/20
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.0%
1/20
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.0%
1/20
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
1/20
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
5.0%
1/20
|
0.00%
0/19
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
10.0%
2/20
|
0.00%
0/19
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/20
|
5.3%
1/19
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20
|
10.5%
2/19
|
|
Nervous system disorders
Headache
|
10.0%
2/20
|
10.5%
2/19
|
|
Nervous system disorders
Paraesthesia
|
5.0%
1/20
|
0.00%
0/19
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/20
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/20
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/20
|
5.3%
1/19
|
|
Vascular disorders
Hypertension
|
0.00%
0/20
|
5.3%
1/19
|
|
Vascular disorders
Hypotension
|
10.0%
2/20
|
0.00%
0/19
|
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