Trial Outcomes & Findings for The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors (NCT NCT00421733)

Last Updated: 2012-01-20

Results Overview

UACR is defined as the ratio: milligram of albumin per gram of creatinine. Baseline UACR was determined as the mean of the 3 UACR measurements from FMV urine collections obtained within 1 week prior to the day of the first dose of study drug. The last on-treatment measurement was the mean of the 3 UACR measurements obtained from FMV urine collections obtained within 1 week of the final week of treatment. The UACR data were log transformed prior to analysis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

281 participants

Primary outcome timeframe

Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

Results posted on

2012-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	Paricalcitol 1 Mcg One paricalcitol 1 mcg capsule and one matching placebo capsule per dose	Paricalcitol 2 Mcg Two paricalcitol 1 mcg capsules per dose	Placebo Two placebo capsules per dose
Overall Study STARTED	93	95	93
Overall Study COMPLETED	78	69	73
Overall Study NOT COMPLETED	15	26	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Paricalcitol 1 Mcg One paricalcitol 1 mcg capsule and one matching placebo capsule per dose	Paricalcitol 2 Mcg Two paricalcitol 1 mcg capsules per dose	Placebo Two placebo capsules per dose
Overall Study Adverse Event	4	9	2
Overall Study Lost to Follow-up	1	2	4
Overall Study Withdrawal by Subject	1	2	7
Overall Study Death	0	3	0
Overall Study Required dialysis	1	0	0
Overall Study Administrative	2	0	0
Overall Study Did not satisfy entry criteria	1	3	2
Overall Study Sponsor request	1	0	3
Overall Study Protocol deviation	4	7	2

Baseline Characteristics

The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paricalcitol 1 Mcg n=93 Participants One paricalcitol 1 mcg capsule and one matching placebo capsule per dose	Paricalcitol 2 Mcg n=95 Participants Two paricalcitol 1 mcg capsules per dose	Placebo n=93 Participants Two placebo capsules per dose	Total n=281 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	47 Participants n=7 Participants	44 Participants n=5 Participants	136 Participants n=4 Participants
Age, Categorical >=65 years	48 Participants n=5 Participants	48 Participants n=7 Participants	49 Participants n=5 Participants	145 Participants n=4 Participants
Age Continuous	64.0 years STANDARD_DEVIATION 10.15 • n=5 Participants	64.7 years STANDARD_DEVIATION 9.92 • n=7 Participants	64.5 years STANDARD_DEVIATION 11.23 • n=5 Participants	64.4 years STANDARD_DEVIATION 10.41 • n=4 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	26 Participants n=7 Participants	33 Participants n=5 Participants	86 Participants n=4 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	69 Participants n=7 Participants	60 Participants n=5 Participants	195 Participants n=4 Participants
Region of Enrollment Portugal	2 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment United States	57 participants n=5 Participants	60 participants n=7 Participants	64 participants n=5 Participants	181 participants n=4 Participants
Region of Enrollment Taiwan	10 participants n=5 Participants	14 participants n=7 Participants	10 participants n=5 Participants	34 participants n=4 Participants
Region of Enrollment Greece	1 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	5 participants n=4 Participants
Region of Enrollment Poland	4 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	12 participants n=4 Participants
Region of Enrollment Spain	11 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants	23 participants n=4 Participants
Region of Enrollment Netherlands	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment Germany	4 participants n=5 Participants	8 participants n=7 Participants	1 participants n=5 Participants	13 participants n=4 Participants
Region of Enrollment Italy	4 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	8 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

Population: Intent-to-treat population, which was all randomized participants who received at least 1 dose of study drug. Subjects without both a baseline and last on-treatment measurement were excluded from the primary efficacy analysis. As such, sample size was N=88 for placebo, N=92 for 1 mcg and for 2 mcg paricalcitol, and N=184 for combined paricalcitol.

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Two placebo capsules per dose (N=88)	Combined Paricalcitol 1 Mcg and 2 Mcg n=184 Participants Combined participants in the 1 mcg and 2 mcg paricalcitol groups (N=92+92=184).	Paricalcitol 1 Mcg n=92 Participants One paricalcitol 1 mcg capsule and one matching placebo capsule per dose	Paricalcitol 2 Mcg n=92 Participants Two paricalcitol 1 mcg capsules per dose
Change From Baseline to the Last On-treatment Measurement in Urine Albumin to Creatinine Ratio (UACR) Levels Determined From the First Morning Void (FMV) Urine Collections Comparing Placebo to the Combined Paricalcitol Treatment Groups (1 Mcg and 2 Mcg).	-0.03 log milligram/gram creatinine Standard Deviation 0.61	-0.18 log milligram/gram creatinine Standard Deviation 0.70	-0.15 log milligram/gram creatinine Standard Deviation 0.72	-0.22 log milligram/gram creatinine Standard Deviation 0.69

SECONDARY outcome

Timeframe: Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

Population: Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline measurement and a last on-treatment visit value were excluded from the analyses.

Number of participants whose last on-treatment albumin to creatinine ratio (UACR) value was reduced at least 15% from the baseline value. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Two placebo capsules per dose (N=88)	Combined Paricalcitol 1 Mcg and 2 Mcg n=92 Participants Combined participants in the 1 mcg and 2 mcg paricalcitol groups (N=92+92=184).	Paricalcitol 1 Mcg n=88 Participants One paricalcitol 1 mcg capsule and one matching placebo capsule per dose	Paricalcitol 2 Mcg Two paricalcitol 1 mcg capsules per dose
Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.	48 Participants	51 Participants	35 Participants	—

SECONDARY outcome

Timeframe: Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

The change is mean change from baseline to the last on-treatment value, with the data being log transformed prior to analysis. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Two placebo capsules per dose (N=88)	Combined Paricalcitol 1 Mcg and 2 Mcg n=72 Participants Combined participants in the 1 mcg and 2 mcg paricalcitol groups (N=92+92=184).	Paricalcitol 1 Mcg n=78 Participants One paricalcitol 1 mcg capsule and one matching placebo capsule per dose	Paricalcitol 2 Mcg Two paricalcitol 1 mcg capsules per dose
Change From Baseline to the Last On-treatment Measurement in Albumin Levels Determined From 24-hour Urine Collection.	-0.10 log milligrams of albumin per 24 hours Standard Deviation 0.73	-0.44 log milligrams of albumin per 24 hours Standard Deviation 0.90	-0.08 log milligrams of albumin per 24 hours Standard Deviation 0.73	—

SECONDARY outcome

Timeframe: Baseline (screening period) through 24 weeks of treatment

Population: Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline and a last on-treatment measurement were excluded from the analyses.

Change is mean change in picograms of iPTH per milliliter of serum.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Two placebo capsules per dose (N=88)	Combined Paricalcitol 1 Mcg and 2 Mcg n=90 Participants Combined participants in the 1 mcg and 2 mcg paricalcitol groups (N=92+92=184).	Paricalcitol 1 Mcg n=88 Participants One paricalcitol 1 mcg capsule and one matching placebo capsule per dose	Paricalcitol 2 Mcg Two paricalcitol 1 mcg capsules per dose
Change From Baseline to the Last On-treatment Observation in Intact Parathyroid Hormone (iPTH) Levels.	-26.7 picogram/milliliter Standard Deviation 55.2	-50.7 picogram/milliliter Standard Deviation 63.1	18.3 picogram/milliliter Standard Deviation 55.3	—

Adverse Events

Paricalcitol 1 Mcg

Serious events: 13 serious events

Other events: 38 other events

Deaths: 0 deaths

Paricalcitol 2 Mcg

Serious events: 19 serious events

Other events: 46 other events

Deaths: 0 deaths

Placebo

Serious events: 12 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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

Measure	Paricalcitol 1 Mcg n=93 participants at risk One paricalcitol 1 mcg capsule and one matching placebo capsule per dose	Paricalcitol 2 Mcg n=95 participants at risk Two paricalcitol 1 mcg capsules per dose	Placebo n=93 participants at risk Two placebo capsules per dose
Blood and lymphatic system disorders Anemia	5.4% 5/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	8.4% 8/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	5.4% 5/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Constipation	3.2% 3/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	2.1% 2/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	1.1% 1/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Diarrhoea	3.2% 3/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	1.1% 1/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	6.5% 6/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Gastrointestinal disorders Nausea	2.2% 2/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	2.1% 2/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	4.3% 4/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Chest pain	0.00% 0/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	3.2% 3/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Fatigue	1.1% 1/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	5.3% 5/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	1.1% 1/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Oedema	3.2% 3/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	3.2% 3/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	1.1% 1/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Oedema peripheral	5.4% 5/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	4.2% 4/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	4.3% 4/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
General disorders Pyrexia	0.00% 0/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	3.2% 3/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Bronchitis	3.2% 3/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	2.1% 2/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	1.1% 1/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Nasopharyngitis	2.2% 2/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	3.2% 3/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	2.2% 2/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Tinea pedis	0.00% 0/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	3.2% 3/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Upper respiratory tract infection	5.4% 5/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	5.3% 5/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	4.3% 4/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Infections and infestations Urinary tract infection	2.2% 2/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	6.3% 6/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	2.2% 2/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Investigations Blood parathyroid hormone decreased	2.2% 2/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	3.2% 3/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Metabolism and nutrition disorders Gout	1.1% 1/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	1.1% 1/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	3.2% 3/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	2.1% 2/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	3.2% 3/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	3.2% 3/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	5.3% 5/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	4.3% 4/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	2.2% 2/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	3.2% 3/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	4.3% 4/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 1/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	4.2% 4/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	2.2% 2/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	1.1% 1/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	5.4% 5/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	2.2% 2/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	3.2% 3/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	4.3% 4/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	2.1% 2/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	3.2% 3/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Nervous system disorders Dizziness	3.2% 3/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	3.2% 3/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	1.1% 1/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Nervous system disorders Headache	0.00% 0/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	3.2% 3/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	4.3% 4/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonsry disease	0.00% 0/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	3.2% 3/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	5.4% 5/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	0.00% 0/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	3.2% 3/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.
Vascular disorders Hypertension	5.4% 5/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	8.4% 8/95 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.	11.8% 11/93 • up to 24 weeks Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.