Trial Outcomes & Findings for Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency (NCT NCT01704079)
NCT ID: NCT01704079
Last Updated: 2025-01-13
Results Overview
Number of subjects in the intent to treat population attaining mean decrease in plasma intact Parathyroid Hormone (iPTH) of ≥30% from P\\pre-treatment baseline in the efficacy assessment phase (EAP) referred to as responders
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
216 participants
Primary outcome timeframe
Approximately 6 months
Results posted on
2025-01-13
Participant Flow
This multicenter study was conducted at 45 investigational sites within the US. Subjects were enrolled and treated from 04 February 2013 through 13 August 2014.
Subjects were stratified by CKD stage and were randomized in a 2:1 ratio to receive a daily 30 μg oral dose of CTAP101 capsules (or matching placebo) for 12 weeks at bedtime. Subjects presenting on a regimen of bone metabolism therapy were to discontinue their prior treatment for at least 28 days' washout (except for bisphosphonates).
Participant milestones
| Measure |
Sugar Pill to CTAP101 30 μg
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
144
|
|
Overall Study
Entered Extension Study
|
53
|
102
|
|
Overall Study
COMPLETED
|
58
|
121
|
|
Overall Study
NOT COMPLETED
|
14
|
23
|
Reasons for withdrawal
| Measure |
Sugar Pill to CTAP101 30 μg
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
|
Overall Study
Adverse Event
|
4
|
7
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Subject noncompliance
|
2
|
3
|
|
Overall Study
Serum Calcium >/= 11.0 mg/dL, repeat con
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
Baseline characteristics by cohort
| Measure |
Sugar Pill to CTAP101 30 μg
n=72 Participants
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
n=144 Participants
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 10.06 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 10.90 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 10.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
144 participants
n=7 Participants
|
216 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 6 monthsPopulation: Intent to treat
Number of subjects in the intent to treat population attaining mean decrease in plasma intact Parathyroid Hormone (iPTH) of ≥30% from P\\pre-treatment baseline in the efficacy assessment phase (EAP) referred to as responders
Outcome measures
| Measure |
Sugar Pill to CTAP101 30 μg
n=72 Participants
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
n=144 Participants
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline
|
5 participants
|
49 participants
|
SECONDARY outcome
Timeframe: Approximately 6 monthsPopulation: Per protocol
Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders
Outcome measures
| Measure |
Sugar Pill to CTAP101 30 μg
n=60 Participants
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
n=119 Participants
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline
|
5 participants
|
47 participants
|
SECONDARY outcome
Timeframe: Approximately 6 monthsPopulation: Intent to treat
Subjects in the intent to treat population with normal serum total 25-hydroxyvitamin D (\>/= 30 ng/dL)
Outcome measures
| Measure |
Sugar Pill to CTAP101 30 μg
n=72 Participants
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
n=144 Participants
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D
|
5 participants
|
120 participants
|
SECONDARY outcome
Timeframe: Approximately 6 monthsPopulation: Per protocol
Subjects in the per protocol population with normal serum total 25-hydroxyvitamin D (\>/= 30 ng/mL)
Outcome measures
| Measure |
Sugar Pill to CTAP101 30 μg
n=60 Participants
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
n=119 Participants
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D
|
5 participants
|
116 participants
|
Adverse Events
Sugar Pill to CTAP101 30 μg
Serious events: 11 serious events
Other events: 18 other events
Deaths: 0 deaths
CTAP101 30 μg Capsules
Serious events: 22 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sugar Pill to CTAP101 30 μg
n=72 participants at risk
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
n=144 participants at risk
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
1.4%
2/144 • Number of events 2 • 6 months from randomization to end of therapy
|
|
Cardiac disorders
Acute myocardial infarction
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Cardiac disorders
Cardiac failure
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
2.1%
3/144 • Number of events 3 • 6 months from randomization to end of therapy
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
General disorders
Asthenia
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
0.00%
0/144 • 6 months from randomization to end of therapy
|
|
General disorders
Chest pain
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
General disorders
Device malfunction
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Hepatobiliary disorders
Cholelitiasis
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Infections and infestations
Cellulitis
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
0.00%
0/144 • 6 months from randomization to end of therapy
|
|
Infections and infestations
Localized infection
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Infections and infestations
Pneumonia
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
2.1%
3/144 • Number of events 3 • 6 months from randomization to end of therapy
|
|
Infections and infestations
Pneumonia bacterial
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
0.00%
0/144 • 6 months from randomization to end of therapy
|
|
Infections and infestations
Sepsis
|
2.8%
2/72 • Number of events 2 • 6 months from randomization to end of therapy
|
0.00%
0/144 • 6 months from randomization to end of therapy
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Investigations
Blood creatinine increased
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
2.1%
3/144 • Number of events 3 • 6 months from randomization to end of therapy
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
2/72 • Number of events 2 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
1.4%
2/144 • Number of events 2 • 6 months from randomization to end of therapy
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
1.4%
2/144 • Number of events 2 • 6 months from randomization to end of therapy
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
0.00%
0/144 • 6 months from randomization to end of therapy
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Nervous system disorders
Dizziness
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Nervous system disorders
Myasthenia gravis crisis
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Nervous system disorders
Status epilepticus
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
0.00%
0/144 • 6 months from randomization to end of therapy
|
|
Nervous system disorders
Syncope
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
1.4%
2/144 • Number of events 2 • 6 months from randomization to end of therapy
|
|
Nervous system disorders
Thalamic infarction
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
0.00%
0/144 • 6 months from randomization to end of therapy
|
|
Psychiatric disorders
Mental status changes
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
0.00%
0/144 • 6 months from randomization to end of therapy
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
0.00%
0/144 • 6 months from randomization to end of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
0.00%
0/144 • 6 months from randomization to end of therapy
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/72 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
Other adverse events
| Measure |
Sugar Pill to CTAP101 30 μg
n=72 participants at risk
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
CTAP101 30 μg Capsules
n=144 participants at risk
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime
Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.6%
4/72 • Number of events 4 • 6 months from randomization to end of therapy
|
3.5%
5/144 • Number of events 5 • 6 months from randomization to end of therapy
|
|
General disorders
Oedema peripheral
|
4.2%
3/72 • Number of events 3 • 6 months from randomization to end of therapy
|
6.2%
9/144 • Number of events 9 • 6 months from randomization to end of therapy
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
1/72 • Number of events 1 • 6 months from randomization to end of therapy
|
5.6%
8/144 • Number of events 8 • 6 months from randomization to end of therapy
|
|
Metabolism and nutrition disorders
Gout
|
6.9%
5/72 • Number of events 5 • 6 months from randomization to end of therapy
|
4.2%
6/144 • Number of events 6 • 6 months from randomization to end of therapy
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
5.6%
4/72 • Number of events 4 • 6 months from randomization to end of therapy
|
0.69%
1/144 • Number of events 1 • 6 months from randomization to end of therapy
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
4/72 • Number of events 4 • 6 months from randomization to end of therapy
|
2.1%
3/144 • Number of events 3 • 6 months from randomization to end of therapy
|
|
Vascular disorders
Hypertension
|
8.3%
6/72 • Number of events 6 • 6 months from randomization to end of therapy
|
5.6%
8/144 • Number of events 8 • 6 months from randomization to end of therapy
|
Additional Information
Douglass Laidlaw, PhD, Vice President, Medical Affairs
OPKO Health, Inc.
Phone: 305-575-4172
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60