Trial Outcomes & Findings for Technology-Assisted Cholesterol Trial in Consumers (TACTiC) (NCT NCT04964544)
NCT ID: NCT04964544
Last Updated: 2024-10-30
Results Overview
Proportion of participants that had a correct tass outcome at their initial TASS assessment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1196 participants
Primary outcome timeframe
Study day -30 to -1, at initial TASS assessment
Results posted on
2024-10-30
Participant Flow
Participant milestones
| Measure |
Nonprescription Rosuvastatin
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
|
|---|---|
|
Overall Study
STARTED
|
1196
|
|
Overall Study
Had an Ask a Doctor Before Use Warning Identified by the CMOG at Final Use Visit
|
25
|
|
Overall Study
Had a do Not Use Warning Identified by the CMOG at Final Use Visit
|
59
|
|
Overall Study
Participants for Whom CMOG Identified a Stop Use Warning at Final Use Assessment
|
2
|
|
Overall Study
COMPLETED
|
1154
|
|
Overall Study
NOT COMPLETED
|
42
|
Reasons for withdrawal
| Measure |
Nonprescription Rosuvastatin
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
|
|---|---|
|
Overall Study
Screen failure or other uncategorised
|
10
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
Withdrawal by Subject
|
18
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
The full analysis set population
Baseline characteristics by cohort
| Measure |
Nonprescription Rosuvastatin
n=1196 Participants
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
|
|---|---|
|
Age, Continuous
|
61.6 Years
STANDARD_DEVIATION 8.1 • n=5 Participants • The full analysis set population
|
|
Age, Customized
Under 20 years of age
|
0 Participants
n=5 Participants
|
|
Age, Customized
20-29 years of age
|
4 Participants
n=5 Participants
|
|
Age, Customized
30-39 years of age
|
18 Participants
n=5 Participants
|
|
Age, Customized
40-49 years of age
|
64 Participants
n=5 Participants
|
|
Age, Customized
50-59 years of age
|
334 Participants
n=5 Participants
|
|
Age, Customized
60-69 years of age
|
598 Participants
n=5 Participants
|
|
Age, Customized
70-75 years of age
|
178 Participants
n=5 Participants
|
|
Age, Customized
76+ years of age
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
474 Participants
n=5 Participants • The full analysis set population
|
|
Sex: Female, Male
Male
|
722 Participants
n=5 Participants • The full analysis set population
|
|
Race/Ethnicity, Customized
White
|
949 Participants
n=5 Participants • The full analysis set population
|
|
Race/Ethnicity, Customized
Hispanic
|
38 Participants
n=5 Participants • The full analysis set population
|
|
Race/Ethnicity, Customized
Black or African American
|
140 Participants
n=5 Participants • The full analysis set population
|
|
Race/Ethnicity, Customized
Asian (China, Philippines, Vietnam, Korea, etc.)
|
34 Participants
n=5 Participants • The full analysis set population
|
|
Race/Ethnicity, Customized
South Asian (India, Pakistan, Bangladesh, etc.)
|
14 Participants
n=5 Participants • The full analysis set population
|
|
Race/Ethnicity, Customized
Other
|
21 Participants
n=5 Participants • The full analysis set population
|
PRIMARY outcome
Timeframe: Study day -30 to -1, at initial TASS assessmentProportion of participants that had a correct tass outcome at their initial TASS assessment
Outcome measures
| Measure |
Nonprescription Rosuvastatin
n=1196 Participants
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
|
|---|---|
|
Overall Correct Initial TASS Outcome, Worst Case Imputation, First Co-Primary Endpoint (Self-Selection Population)
|
1085 Participants
|
PRIMARY outcome
Timeframe: From enrollment to end of the home use period at 180 days, at final TASS AssessmentProportion of participants that had a correct tass outcome at their final TASS assessment
Outcome measures
| Measure |
Nonprescription Rosuvastatin
n=1154 Participants
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
|
|---|---|
|
Overall Correct Final Use Outcome With Mitigation, Second Co-primary Endpoint (Per Protocol Population)
|
1132 Participants
|
PRIMARY outcome
Timeframe: From enrollment to end of the home use period at 180 days, at final assessmentOutcome measures
| Measure |
Nonprescription Rosuvastatin
n=1063 Participants
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
|
|---|---|
|
Percent Change From Baseline in Verified LDL-C Regardless of Final Use Outcome (AUS ITT Population)
|
-35.48 Percent change of baseline
Interval -36.63 to -34.33
|
SECONDARY outcome
Timeframe: From enrollment to end of the home use period at 180 daysPopulation: Participants in the per protocol analysis set eligble for continuous treatment
Outcome measures
| Measure |
Nonprescription Rosuvastatin
n=910 Participants
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
|
|---|---|
|
Participants Eligble for Continuous Treatment Who Self-Tested With a Verified LDL-C Retest During Study, Overall and by Subgroups (Per Protocol Population)
|
845 Participants
|
SECONDARY outcome
Timeframe: From enrollment to end of the home use period at 180 daysPopulation: Participants who had a stop use warning identified by the CMOG at final use assessment
Participants who Self-Identify a Stop Use Warning also identified by the CMOG, and Stop Medication.
Outcome measures
| Measure |
Nonprescription Rosuvastatin
n=2 Participants
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
|
|---|---|
|
Participants Who Self-Identify a Stop Use Warning Also Identified by the CMOG, and Stop Medication (Per Protocol Population)
|
1 Participants
|
SECONDARY outcome
Timeframe: From enrollment to end of the home use period at 180 daysPopulation: Participants in the per protocol population who had a do not use warning identified by the CMOG at final use visit
Outcome measures
| Measure |
Nonprescription Rosuvastatin
n=59 Participants
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
|
|---|---|
|
Participants Who Self-Identify a Do Not Use Warning Also Identified by the CMOG at Final Use Assessment(Per Protocol Population, Participants Who Had a do Not Use Warning Identified by the CMOG at Final Use Visit)
|
46 Participants
|
SECONDARY outcome
Timeframe: From enrollment to end of the home use period at 180 daysPopulation: Participants in the per protocol population who had an ask a doctor before use warning identified by the CMOG at final use visit
Outcome measures
| Measure |
Nonprescription Rosuvastatin
n=25 Participants
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
|
|---|---|
|
Participants Who Self-Identify an Ask a Doctor Before Use Warning Also Identified by the CMOG at Final Use Assessment (Per Protocol Population, Participants Who Had a do Not Use Warning Identified by the CMOG at Final Use Visit)
|
23 Participants
|
SECONDARY outcome
Timeframe: From enrollment to end of the home use period at 180 daysPopulation: Participants in the per protocol population whose overall compliance was assessed
Overall compliance is defined as 100 \* (total number of pills taken) / (Intended duration of treatment in days)
Outcome measures
| Measure |
Nonprescription Rosuvastatin
n=1146 Participants
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
|
|---|---|
|
Participants With Overall Compliance Between 50% and 120%
|
1089 Participants
|
SECONDARY outcome
Timeframe: From enrollment to end of the home use period at 180 daysPopulation: Participants in the per protocol population for whom supply period compliance was assessed across all supply periods
An individual is longitudinally compliant if they have 50% to 120% compliance across each supply period.
Outcome measures
| Measure |
Nonprescription Rosuvastatin
n=1134 Participants
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
|
|---|---|
|
Participants Who Were Longitudinally Compliant (Per Protocol Population)
|
848 Participants
|
SECONDARY outcome
Timeframe: From enrollment to end of the home use period at 180 daysPopulation: Participants in the per protocol population that were eligible for continuous treatment
An individual is persistent if they ordered the full 180 days of treatment and were eligible for continuous treatment
Outcome measures
| Measure |
Nonprescription Rosuvastatin
n=910 Participants
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
|
|---|---|
|
Participants Who Were Persistent (Per Protocol Population)
|
896 Participants
|
Adverse Events
Nonprescription Rosuvastatin
Serious events: 27 serious events
Other events: 493 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Nonprescription Rosuvastatin
n=1177 participants at risk
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
|
|---|---|
|
Gastrointestinal disorders
Gastric ulcer
|
0.17%
2/1177 • Number of events 2 • treatment period (6 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
General disorders
Sudden death
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Infections and infestations
Covid-19
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Infections and infestations
Diverticulitis
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Infections and infestations
Pneumonia
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Infections and infestations
Pneumonia bacterial
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Infections and infestations
Pneumonia viral
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Cardiac disorders
Atrial fibrillation
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chromophobe renal cell carcinoma
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Cardiac disorders
Atrial flutter
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.17%
2/1177 • Number of events 2 • treatment period (6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Nervous system disorders
Epilepsy
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Nervous system disorders
Intracranial aneurysm
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Cardiac disorders
Myocardial infarction
|
0.17%
2/1177 • Number of events 2 • treatment period (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.08%
1/1177 • Number of events 3 • treatment period (6 months)
|
|
Vascular disorders
Aortic aneurysm
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Vascular disorders
Hypertensive urgency
|
0.08%
1/1177 • Number of events 1 • treatment period (6 months)
|
|
Cardiac disorders
Tachycardia
|
0.08%
1/1177 • Number of events 2 • treatment period (6 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.17%
2/1177 • Number of events 2 • treatment period (6 months)
|
Other adverse events
| Measure |
Nonprescription Rosuvastatin
n=1177 participants at risk
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
2.2%
26/1177 • Number of events 27 • treatment period (6 months)
|
|
General disorders
Fatigue
|
4.2%
49/1177 • Number of events 52 • treatment period (6 months)
|
|
General disorders
Pain
|
2.7%
32/1177 • Number of events 33 • treatment period (6 months)
|
|
General disorders
Pyrexia
|
1.8%
21/1177 • Number of events 21 • treatment period (6 months)
|
|
Infections and infestations
Covid-19
|
1.4%
17/1177 • Number of events 17 • treatment period (6 months)
|
|
Infections and infestations
Sinusitis
|
1.1%
13/1177 • Number of events 13 • treatment period (6 months)
|
|
Infections and infestations
Suspected covid-19
|
1.2%
14/1177 • Number of events 14 • treatment period (6 months)
|
|
Infections and infestations
Urinary tract infection
|
2.2%
26/1177 • Number of events 27 • treatment period (6 months)
|
|
Investigations
Sars-cov-2 test positive
|
10.7%
126/1177 • Number of events 129 • treatment period (6 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
83/1177 • Number of events 113 • treatment period (6 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.5%
41/1177 • Number of events 44 • treatment period (6 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.5%
41/1177 • Number of events 51 • treatment period (6 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
49/1177 • Number of events 66 • treatment period (6 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.2%
14/1177 • Number of events 15 • treatment period (6 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
51/1177 • Number of events 59 • treatment period (6 months)
|
|
Nervous system disorders
Dizziness
|
1.9%
22/1177 • Number of events 22 • treatment period (6 months)
|
|
Nervous system disorders
Headache
|
5.9%
69/1177 • Number of events 81 • treatment period (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
50/1177 • Number of events 52 • treatment period (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.3%
15/1177 • Number of events 17 • treatment period (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.4%
28/1177 • Number of events 30 • treatment period (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.2%
14/1177 • Number of events 14 • treatment period (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.5%
30/1177 • Number of events 33 • treatment period (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.0%
12/1177 • Number of events 13 • treatment period (6 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
14/1177 • Number of events 14 • treatment period (6 months)
|
|
Vascular disorders
Hypertensive urgency
|
1.7%
20/1177 • Number of events 20 • treatment period (6 months)
|
|
Gastrointestinal disorders
Constipation
|
1.4%
17/1177 • Number of events 18 • treatment period (6 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
41/1177 • Number of events 47 • treatment period (6 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of this study may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER