Trial Outcomes & Findings for Rosuvastatin Adherence App Study in China (NCT NCT02433288)

Last Updated: 2019-01-31

Results Overview

The time from randomization to last patient reported visit (prior to the end-of-study visit) to a doctor to get a prescription for rosuvastatin plus the number of days of medicine provided in that last prescription.

Recruitment status

COMPLETED

Study phase

Target enrollment

885 participants

Primary outcome timeframe

limited to 169 days

Results posted on

2019-01-31

Participant Flow

885 patients signed Inform Consent and were randomized in the study, 443 subjects in the active group and 442 subjects in the control group. 320 (72.2%) and 316 (71.5%) patients, respectively, completed the study. The overall completion rate was 71.9%. 31 patients (12 and 19 respectively) was not successful in receiving the relevant application.

A total of 885 patients were randomized (1:1) to two groups: an active group which received the smart phone-based patient support tool and a control application used for data collection only.

Participant milestones

Participant milestones
Measure	Active Group receive the smart phone-based patient support tool	Control Group provided only the control application and not the smart phone-based patient support tool
Overall Study STARTED	443	442
Overall Study COMPLETED	320	316
Overall Study NOT COMPLETED	123	126

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Group receive the smart phone-based patient support tool	Control Group provided only the control application and not the smart phone-based patient support tool
Overall Study Severe non-compliance to protocol	13	7
Overall Study Eligibility criteria not fullfilled	7	3
Overall Study Withdrawal by Subject	101	99
Overall Study Lost to Follow-up	2	14
Overall Study Death	0	3

Baseline Characteristics

Rosuvastatin Adherence App Study in China

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Group n=431 Participants receive the smart phone-based patient support tool	Control Group n=423 Participants provided only the control application and not the smart phone-based patient support tool	Total n=854 Participants Total of all reporting groups
Age, Continuous	54.7 Years STANDARD_DEVIATION 9.80 • n=5 Participants	54.5 Years STANDARD_DEVIATION 9.51 • n=7 Participants	54.6 Years STANDARD_DEVIATION 9.65 • n=5 Participants
Sex: Female, Male Female	161 Participants n=5 Participants	154 Participants n=7 Participants	315 Participants n=5 Participants
Sex: Female, Male Male	270 Participants n=5 Participants	269 Participants n=7 Participants	539 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	431 Participants n=5 Participants	423 Participants n=7 Participants	854 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	431 Participants n=5 Participants	423 Participants n=7 Participants	854 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: limited to 169 days

Population: FAS

Outcome measures

Outcome measures
Measure	Active Group n=431 Participants receive the smart phone-based patient support tool	Control Group n=423 Participants provided only the control application and not the smart phone-based patient support tool
Duration of Treatment	156.7 days Standard Error 2.24	146.0 days Standard Error 2.69

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: FAS

The number of patients who answered 'Yes' to Q4 of Rosuvastatin Adherence Questionnaire (RAQ) at all time points divided by the total number of randomized patients.

Outcome measures

Outcome measures
Measure	Active Group n=431 Participants receive the smart phone-based patient support tool	Control Group n=423 Participants provided only the control application and not the smart phone-based patient support tool
Percentage of Fully Adherent Patients	4.4 % of patients	9.9 % of patients

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: FAS

The number of reported rosuvastatin tablets taken divided by the total number of days in the study.

Outcome measures

Outcome measures
Measure	Active Group n=200 Participants receive the smart phone-based patient support tool	Control Group n=219 Participants provided only the control application and not the smart phone-based patient support tool
Treatment Adherence	37.95 % adherence Standard Deviation 32.916	58.19 % adherence Standard Deviation 36.257

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS

Low-Density Lipoprotein-Cholesterol (LDL-C) change from baseline at the Week 24 assessment for subjects who completed 24 weeks of treatment

Outcome measures

Outcome measures
Measure	Active Group n=303 Participants receive the smart phone-based patient support tool	Control Group n=303 Participants provided only the control application and not the smart phone-based patient support tool
Percent Change in Low-Density Lipoprotein-Cholesterol (LDL-C) From Baseline	-21.09 % change Standard Error 1.40	-21.72 % change Standard Error 1.40

POST_HOC outcome

Timeframe: Up to 24 weeks

Population: FAS

The number of reported rosuvastatin tablets taken divided by the total number of days reported during the treatment. This is eliminated any missing data from the calculation.

Outcome measures

Outcome measures
Measure	Active Group n=200 Participants receive the smart phone-based patient support tool	Control Group n=219 Participants provided only the control application and not the smart phone-based patient support tool
Reported Treatment Adherence	94.63 % adherence Standard Deviation 18.347	96.01 % adherence Standard Deviation 14.316

Adverse Events

Active Group

Serious events: 23 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Traxler, Barry M

AstraZeneca

Phone: +1 301 398 0657

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Active Group n=431 participants at risk receive the smart phone-based patient support tool	Control Group n=423 participants at risk provided only the control application and not the smart phone-based patient support tool
Vascular disorders Left carotid artery occlusion	0.23% 1/431 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Vascular disorders Right carotid artery stenosis	0.23% 1/431 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Cardiac failure	0.23% 1/431 • Number of events 3 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Cardiac insufficiency	0.23% 1/431 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Cardiac neurosis	0.46% 2/431 • Number of events 2 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Complete right bundle branch block	0.23% 1/431 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Coronary atherosclerosis	0.00% 0/431 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.24% 1/423 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Coronary atherosclerotic heart disease	0.93% 4/431 • Number of events 4 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.24% 1/423 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Coronary heart disease	0.46% 2/431 • Number of events 2 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	1.2% 5/423 • Number of events 5 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Dilated cardiomyopathy	0.23% 1/431 • Number of events 3 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Myocardial infarction	0.23% 1/431 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Persistent atrial fibrillation	0.00% 0/431 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.24% 1/423 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Unstable angina pectoris	0.23% 1/431 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.24% 1/423 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Ventricular premature beat	0.23% 1/431 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Eye disorders Macular edema	0.00% 0/431 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.24% 1/423 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Gastrointestinal disorders Constipation	0.23% 1/431 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
General disorders Dizziness	0.00% 0/431 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.24% 1/423 • Number of events 2 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
General disorders Somatization disorder	0.23% 1/431 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Limb mass	0.23% 1/431 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Nervous system disorders Acute cerebral infarction	0.23% 1/431 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Nervous system disorders Cerebral infarction	0.23% 1/431 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Renal and urinary disorders Acute renal insufficiency	0.23% 1/431 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Renal and urinary disorders Chronic glomerulonephritis	0.23% 1/431 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.46% 2/431 • Number of events 2 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Pulmonary infection	0.23% 1/431 • Number of events 1 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.	0.00% 0/423 • 177±7 days This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.