Trial Outcomes & Findings for A Study of Subcutaneous Mircera in Participants With Chronic Kidney Disease Not Treated With ESA or on Dialysis (NCT NCT00559637)
NCT ID: NCT00559637
Last Updated: 2016-04-06
Results Overview
Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-12 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
184 participants
Primary outcome timeframe
Evaluation phase (Months 8 and 9)
Results posted on
2016-04-06
Participant Flow
Participant milestones
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 micrograms per kilogram (mcg/kg) of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
|
|---|---|
|
Overall Study
STARTED
|
184
|
|
Overall Study
COMPLETED
|
130
|
|
Overall Study
NOT COMPLETED
|
54
|
Reasons for withdrawal
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 micrograms per kilogram (mcg/kg) of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
|
|---|---|
|
Overall Study
Adverse Event
|
22
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Withdrawal criteria fulfilled
|
4
|
|
Overall Study
Failure to return
|
6
|
|
Overall Study
Insufficient response
|
3
|
|
Overall Study
Started requiring dialysis after month 7
|
2
|
|
Overall Study
Suspected lung cancer
|
1
|
|
Overall Study
Participation in another study
|
1
|
|
Overall Study
Delayed administration of C.E.R.A
|
1
|
|
Overall Study
Change of center
|
1
|
|
Overall Study
Change of home
|
1
|
|
Overall Study
Inclusion or exclusion criteria violated
|
2
|
Baseline Characteristics
A Study of Subcutaneous Mircera in Participants With Chronic Kidney Disease Not Treated With ESA or on Dialysis
Baseline characteristics by cohort
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=184 Participants
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
|
|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 15.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Evaluation phase (Months 8 and 9)Population: Intent to treat (ITT) population included all participants who received at least one dose of study medication with at least one hemoglobin value measured during treatment period.
Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-12 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=178 Participants
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
|
|---|---|
|
Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL)
|
10.67 percentage of participants
Interval 6.55 to 16.17
|
PRIMARY outcome
Timeframe: Evaluation phase (Months 8 and 9)Population: ITT population
Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-13 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=178 Participants
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
|
|---|---|
|
Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-13 g/dL
|
29.21 percentage of participants
Interval 22.65 to 36.48
|
PRIMARY outcome
Timeframe: Baseline, evaluation phase (Months 8 and 9)Population: ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.
The change from the baseline hemoglobin value to the mean hemoglobin value of the evaluation phase was only calculated if both the baseline value and the mean of the evaluation phase (mean of Months 8 and 9) were available. In case of only one available hemoglobin value within the evaluation phase, that single value replaced the mean.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=131 Participants
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
|
|---|---|
|
Change From Baseline in Hemoglobin Value to the Evaluation Phase
|
1.6 g/dL
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Baseline to Month 9Population: ITT population
The duration of hemoglobin values staying within the range of 11-12 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=178 Participants
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
|
|---|---|
|
Duration of Hemoglobin Values in the Range of 11-12 g/dL
|
2.40 months
Standard Deviation 1.796
|
SECONDARY outcome
Timeframe: Baseline to Month 9Population: ITT population
The duration of hemoglobin values staying within the range of 11-13 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=178 Participants
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
|
|---|---|
|
Duration of Hemoglobin Values in the Range of 11-13 g/dL
|
3.62 months
Standard Deviation 2.450
|
SECONDARY outcome
Timeframe: Baseline to Month 9Population: ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.
The duration (number of months) until the hemoglobin value exceeded 11 g/dL for the first time was summarized for participants for whom at least one measured hemoglobin value exceeded 11 g/dL.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=152 Participants
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
|
|---|---|
|
Time to Increase of Hemoglobin Value to Over 11 g/dL
|
2.28 months
Standard Deviation 1.649
|
SECONDARY outcome
Timeframe: Baseline until Month 8Population: ITT population
A dose adjustment was defined as a change versus the preceding dose. It included dose increase, dose reduction and dose interruption. An interruption (no dose given) was always counted as a dose adjustment, regardless of whether or not at the previous time point a dose had been administered. After an interruption a change in the dose relative to the dose given before the interruption was counted as a dose adjustment.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=178 Participants
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
|
|---|---|
|
Total Number of Dose Adjustments
Total number of dose adjustments
|
595 dose adjustments
|
|
Total Number of Dose Adjustments
Total number of dose increases
|
249 dose adjustments
|
|
Total Number of Dose Adjustments
Total number of dose reductions
|
210 dose adjustments
|
|
Total Number of Dose Adjustments
Total number of dose interruptions
|
136 dose adjustments
|
SECONDARY outcome
Timeframe: Baseline to Month 9Population: ITT population
RBC transfusions could be given during the study, if medically necessary, i.e., in participants with severe anemia with distinct symptoms or signs of anemia (such as in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=178 Participants
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
|
|---|---|
|
Total Number of Red Blood Cell (RBC) Transfusions
|
39 number of transfusions
|
Adverse Events
Methoxy Polyethylene Glycol-epoetin Beta
Serious events: 88 serious events
Other events: 109 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=184 participants at risk
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
|
|---|---|
|
Renal and urinary disorders
Renal failure
|
14.7%
27/184 • Baseline to Month 11
Safety population
|
|
Renal and urinary disorders
Renal failure chronic
|
4.3%
8/184 • Baseline to Month 11
Safety population
|
|
Renal and urinary disorders
Renal impairment
|
2.7%
5/184 • Baseline to Month 11
Safety population
|
|
Renal and urinary disorders
Renal failure acute
|
1.1%
2/184 • Baseline to Month 11
Safety population
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
6.5%
12/184 • Baseline to Month 11
Safety population
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
3.3%
6/184 • Baseline to Month 11
Safety population
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
3/184 • Baseline to Month 11
Safety population
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
2.7%
5/184 • Baseline to Month 11
Safety population
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
1.1%
2/184 • Baseline to Month 11
Safety population
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Injury, poisoning and procedural complications
Fall
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Cardiac disorders
Cardiac failure
|
2.2%
4/184 • Baseline to Month 11
Safety population
|
|
Cardiac disorders
Angina unstable
|
1.1%
2/184 • Baseline to Month 11
Safety population
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
2/184 • Baseline to Month 11
Safety population
|
|
Cardiac disorders
Tachyarrhythmia
|
1.1%
2/184 • Baseline to Month 11
Safety population
|
|
Cardiac disorders
Bradycardia
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Cardiac disorders
Cardiogenic shock
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Cardiac disorders
Myocardial infarction
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Cardiac disorders
Pericardial effusion
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Infections and infestations
Sepsis
|
1.6%
3/184 • Baseline to Month 11
Safety population
|
|
Infections and infestations
Bronchitis
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Infections and infestations
Bronchopneumonia
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Infections and infestations
Cystitis
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Infections and infestations
Gastroenteritis
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Infections and infestations
Meningitis enterococcal
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Infections and infestations
Pneumonia
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Infections and infestations
Postoperative wound infection
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Infections and infestations
Tracheobronchitis
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Infections and infestations
Urinary tract infection
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
1.1%
2/184 • Baseline to Month 11
Safety population
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Gastrointestinal disorders
Abdominal pain
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
General disorders
Drug ineffective
|
1.1%
2/184 • Baseline to Month 11
Safety population
|
|
General disorders
Medical device complication
|
1.1%
2/184 • Baseline to Month 11
Safety population
|
|
General disorders
Device dislocation
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
General disorders
Device malfunction
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
General disorders
Oedema
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
General disorders
Pyrexia
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
2/184 • Baseline to Month 11
Safety population
|
|
Metabolism and nutrition disorders
Cachexia
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Metabolism and nutrition disorders
Dehydration
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
2/184 • Baseline to Month 11
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
2/184 • Baseline to Month 11
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Vascular disorders
Deep vein thrombosis
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Vascular disorders
Haematoma
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Vascular disorders
Poor peripheral circulation
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Vascular disorders
Venous thrombosis limb
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Investigations
Haemoglobin decreased
|
1.1%
2/184 • Baseline to Month 11
Safety population
|
|
Investigations
Blood pressure increased
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Investigations
Blood sodium decreased
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Nervous system disorders
Cerebrovascular accident
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Nervous system disorders
Ischaemic stroke
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.1%
2/184 • Baseline to Month 11
Safety population
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Immune system disorders
Kidney transplant rejection
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Ear and labyrinth disorders
Vertigo
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
|
Eye disorders
Retinal artery occlusion
|
0.54%
1/184 • Baseline to Month 11
Safety population
|
Other adverse events
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=184 participants at risk
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
7.1%
13/184 • Baseline to Month 11
Safety population
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
9.2%
17/184 • Baseline to Month 11
Safety population
|
|
Gastrointestinal disorders
Nausea
|
7.1%
13/184 • Baseline to Month 11
Safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
12/184 • Baseline to Month 11
Safety population
|
|
General disorders
Oedema
|
15.2%
28/184 • Baseline to Month 11
Safety population
|
|
General disorders
Oedema peripheral
|
10.9%
20/184 • Baseline to Month 11
Safety population
|
|
General disorders
Fatigue
|
5.4%
10/184 • Baseline to Month 11
Safety population
|
|
Infections and infestations
Bronchitis
|
6.0%
11/184 • Baseline to Month 11
Safety population
|
|
Infections and infestations
Urinary tract infection
|
5.4%
10/184 • Baseline to Month 11
Safety population
|
|
Metabolism and nutrition disorders
Iron deficiency
|
7.1%
13/184 • Baseline to Month 11
Safety population
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.0%
11/184 • Baseline to Month 11
Safety population
|
|
Metabolism and nutrition disorders
Acidosis
|
5.4%
10/184 • Baseline to Month 11
Safety population
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
13/184 • Baseline to Month 11
Safety population
|
|
Vascular disorders
Hypertension
|
30.4%
56/184 • Baseline to Month 11
Safety population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER