Trial Outcomes & Findings for Study of the Use of Niaspan for Treatment of Dyslipidemia in Diabetic Nephropathy (NCT NCT00108485)
NCT ID: NCT00108485
Last Updated: 2016-06-22
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
9 participants
Primary outcome timeframe
Baseline, 1 year
Results posted on
2016-06-22
Participant Flow
Participant milestones
| Measure |
Extended Release Niacin
Extended release niacin 1500-2000 mg daily versus placebo comparator
Extended release niacin: Extended release niacin 1500-2000mg once daily
|
Placebo
Placebo tablets
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Extended Release Niacin
Extended release niacin 1500-2000 mg daily versus placebo comparator
Extended release niacin: Extended release niacin 1500-2000mg once daily
|
Placebo
Placebo tablets
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Study of the Use of Niaspan for Treatment of Dyslipidemia in Diabetic Nephropathy
Baseline characteristics by cohort
| Measure |
Extended Release Niacin
n=5 Participants
Extended release niacin 1500-2000 mg daily versus placebo comparator
Extended release niacin: Extended release niacin 1500-2000mg once daily
|
Placebo
n=4 Participants
Placebo tablets
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 yearPopulation: Nine participants were enrolled into this study, however baseline data is only available for 2 participants (1 from the Extended Release Niacin arm and 1 from the Placebo arm). Data was only analyzed for 2 participants.
Outcome measures
| Measure |
Extended Release Niacin
n=1 Participants
Extended release niacin 1500-2000 mg daily versus placebo comparator
Extended release niacin: Extended release niacin 1500-2000mg once daily
|
Placebo
n=1 Participants
Placebo tablets
|
|---|---|---|
|
Change in Proteinuria
|
42 mg/dL
|
63 mg/dL
|
Adverse Events
Extended Release Niacin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Extended Release Niacin
n=5 participants at risk
Extended release niacin 1500-2000 mg daily versus placebo comparator
Extended release niacin: Extended release niacin 1500-2000mg once daily
|
Placebo
n=4 participants at risk
Placebo tablets
|
|---|---|---|
|
Eye disorders
Blurred Vision
|
20.0%
1/5 • Number of events 1
Solicited by questionnaire.
|
0.00%
0/4
Solicited by questionnaire.
|
|
Vascular disorders
Subpleural Nodule
|
20.0%
1/5 • Number of events 1
Solicited by questionnaire.
|
0.00%
0/4
Solicited by questionnaire.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/5
Solicited by questionnaire.
|
25.0%
1/4 • Number of events 1
Solicited by questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Bilateral Calf Pain
|
0.00%
0/5
Solicited by questionnaire.
|
25.0%
1/4 • Number of events 1
Solicited by questionnaire.
|
|
Vascular disorders
Flushing
|
20.0%
1/5 • Number of events 1
Solicited by questionnaire.
|
0.00%
0/4
Solicited by questionnaire.
|
|
Skin and subcutaneous tissue disorders
Itching Upper Extremeties
|
20.0%
1/5 • Number of events 1
Solicited by questionnaire.
|
0.00%
0/4
Solicited by questionnaire.
|
|
General disorders
Chest Pain
|
20.0%
1/5 • Number of events 1
Solicited by questionnaire.
|
0.00%
0/4
Solicited by questionnaire.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5
Solicited by questionnaire.
|
25.0%
1/4 • Number of events 1
Solicited by questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Back and Shoulder Pain
|
0.00%
0/5
Solicited by questionnaire.
|
25.0%
1/4 • Number of events 1
Solicited by questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Leg Muscle Pain
|
0.00%
0/5
Solicited by questionnaire.
|
25.0%
1/4 • Number of events 1
Solicited by questionnaire.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place