Trial Outcomes & Findings for Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease (NCT NCT01071070)
NCT ID: NCT01071070
Last Updated: 2012-01-26
Results Overview
The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
216 participants
Primary outcome timeframe
Baseline to 12 Weeks
Results posted on
2012-01-26
Participant Flow
Participants were enrolled in the study at investigative sites in China. Recruitment began in October 2009 and ended in July 2010. The study population consisted of participants with Stage 5 chronic kidney disease who were receiving hemodialysis.
If subjects were receiving vitamin D receptor (VDR) activators, they participated in a Washout Phase for 2 weeks prior to entering into the Screening Phase in order to wash out any VDR activators and their potential hysteresis or carryover effects.
Participant milestones
| Measure |
Group 1
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
|
Group 2
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
108
|
|
Overall Study
COMPLETED
|
104
|
105
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Group 1
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
|
Group 2
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Missed 3 consecutive doses of study drug
|
2
|
0
|
|
Overall Study
Hypercalcemia
|
1
|
0
|
Baseline Characteristics
Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Group 1
n=108 Participants
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
|
Group 2
n=108 Participants
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
50.5 years
STANDARD_DEVIATION 13.55 • n=93 Participants
|
50.8 years
STANDARD_DEVIATION 12.67 • n=4 Participants
|
50.6 years
STANDARD_DEVIATION 13.09 • n=27 Participants
|
|
Age, Customized
< 65 years
|
91 Participants
n=93 Participants
|
93 Participants
n=4 Participants
|
184 Participants
n=27 Participants
|
|
Age, Customized
>=65 years
|
17 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
|
Region of Enrollment
China
|
108 participants
n=93 Participants
|
108 participants
n=4 Participants
|
216 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 WeeksPopulation: The analysis was based on the per-protocol population, which consisted of all randomized participants who completed at least 6 weeks of treatment and met the conditions that defined the per-protocol population.
The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values
Outcome measures
| Measure |
Group 1
n=105 Participants
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
|
Group 2
n=102 Participants
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
|
|---|---|---|
|
The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels
Yes
|
93 participants
|
57 participants
|
|
The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels
No
|
12 participants
|
45 participants
|
SECONDARY outcome
Timeframe: Baseline to 12 WeeksPopulation: The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL
Outcome measures
| Measure |
Group 1
n=108 Participants
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
|
Group 2
n=108 Participants
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
|
|---|---|---|
|
The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL
Yes
|
19 participants
|
21 participants
|
|
The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL
No
|
89 participants
|
87 participants
|
SECONDARY outcome
Timeframe: Baseline to 12 WeeksPopulation: The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Group 1
n=108 Participants
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
|
Group 2
n=108 Participants
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
|
|---|---|---|
|
The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value
|
-342.57 pg/mL
Standard Error 43.82
|
-191.53 pg/mL
Standard Error 43.82
|
SECONDARY outcome
Timeframe: Baseline to 12 WeeksPopulation: The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Group 1
n=108 Participants
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
|
Group 2
n=108 Participants
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
|
|---|---|---|
|
The Change From Baseline to the Final Observation in Calcium
|
0.64 mg/dL
Standard Error 0.06
|
0.59 mg/dL
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline to 12 WeeksPopulation: The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Group 1
n=108 Participants
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
|
Group 2
n=108 Participants
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
|
|---|---|---|
|
The Change From Baseline to the Final Observation in Calcium-phosphorus Product
|
7.53 mg^2/dL^2
Standard Error 1.47
|
8.15 mg^2/dL^2
Standard Error 1.47
|
SECONDARY outcome
Timeframe: Baseline to 12 WeeksPopulation: The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Group 1
n=108 Participants
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
|
Group 2
n=108 Participants
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
|
|---|---|---|
|
The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure
|
-1.47 mm Hg
Standard Deviation 19.76
|
-1.75 mm Hg
Standard Deviation 21.03
|
SECONDARY outcome
Timeframe: Baseline to 12 WeeksPopulation: The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Group 1
n=108 Participants
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
|
Group 2
n=108 Participants
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
|
|---|---|---|
|
The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure
|
-1.47 mm Hg
Standard Deviation 11.31
|
-0.32 mm Hg
Standard Deviation 13.68
|
SECONDARY outcome
Timeframe: Baseline to 12 WeeksPopulation: The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Group 1
n=108 Participants
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
|
Group 2
n=108 Participants
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
|
|---|---|---|
|
The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate
|
0.51 beats per minute
Standard Deviation 9.48
|
-0.89 beats per minute
Standard Deviation 11.38
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.
The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L)
Outcome measures
| Measure |
Group 1
n=108 Participants
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
|
Group 2
n=108 Participants
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
|
|---|---|---|
|
The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)
Yes
|
1 participants
|
0 participants
|
|
The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)
No
|
107 participants
|
108 participants
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Group 2
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=108 participants at risk
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
|
Group 2
n=108 participants at risk
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
|
|---|---|---|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
Other adverse events
| Measure |
Group 1
n=108 participants at risk
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
|
Group 2
n=108 participants at risk
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
|
|---|---|---|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Cardiac disorders
Palpitations
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
2/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
1.9%
2/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Gastrointestinal disorders
Enteritis
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Gastrointestinal disorders
Gingivitis
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Gastrointestinal disorders
Vomiting
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
General disorders
Chest discomfort
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
General disorders
Chest pain
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
General disorders
Oedema peripheral
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
General disorders
Pyrexia
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
1.9%
2/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Infections and infestations
Pharyngitis
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Infections and infestations
Respiratory tract infection
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
8/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
5.6%
6/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
1.9%
2/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Investigations
Alanine aminotransferase increased
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Investigations
Aspartate aminotransferase increased
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.9%
2/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.9%
2/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Nervous system disorders
Dizziness
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
1.9%
2/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Nervous system disorders
Headache
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Psychiatric disorders
Insomnia
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
1.9%
2/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
2/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.8%
3/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Vascular disorders
Hypertension
|
2.8%
3/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
|
Vascular disorders
Hypotension
|
0.93%
1/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
0.00%
0/108 • From the time of study drug administration until 30 days following discontinuation of study drug administration.
|
Additional Information
Global Medical Services
Abbott
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER