Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SHUKRA |
Not provided
Not provided
Not provided
Due to inadequate recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the effectiveness and safety of rosuvastatin 5mg in lowering blood cholesterol, compared to one other medicine, atorvastatin 10mg in Asian patients in the UK.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rosuvastatin | Active Comparator | rosuvastatin 5 mg |
|
| atorvastatin | Active Comparator | atorvastatin 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary advice | Behavioral |
| ||
| rosuvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C) | Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100 | 6 weeks (baseline) and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L | 6 weeks (Baseline) and 12 weeks | |
| The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rhiannon Rowsell, MD | AstraZeneca | Study Director |
| Shahid Ali, MD | Bradford PCT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Allerton | United Kingdom | ||||
| Research Site |
Participants entered an initial 6-week dietary run-in/ wash-out period, after which those with a fasting low density lipoprotein cholesterol (LDL-C) of greater than or equal to 4.00 mmol/L and triglycerides (TG) less than 4.52 mmol/L, were randomised to receive treatment with either rosuvastatin 5 mg plus atorvatstatin , or atorvastatin 10mg
Participants were recruited from 25 primary and secondary care centres in the United Kingdom. The first participant was enrolled on 20th December 2006 and the last participant entered the study on 16th November 2007.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rosuvastatin | rosuvastatin 5 mg |
| FG001 | Atorvastatin | atorvastatin 10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
rosuvastatin 5 mg |
|
|
| atorvastatin | Drug | atorvastatin 10 mg |
|
| 6 weeks (baseline) and 12 weeks |
| The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category, and the Combined LDL-C and TC Target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, Both Depending on Risk Category. | Risk categories are: Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L Patients are defined as symptomatic if they meet at least 1 of the following criteria: History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg Total risk is derived from age, sex, TC, systolic BP and smoking status. | 6 weeks (baseline) and 12 weeks |
| The Percentage Change From Baseline(week6) in TC | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | 6 weeks (baseline) and 12 weeks |
| The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C) | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | 6 weeks (baseline) and 12 weeks |
| The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L | 6 weeks (baseline) and 12 weeks |
| The Percentage Change From Baseline (Week 6)in Non-HDL-C | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | 6 weeks (baseline) and 12 weeks |
| The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB) | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | 6 weeks (baseline) and 12 weeks |
| The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1) | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | 6 weeks (baseline) and 12 weeks |
| The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | 6 weeks (baseline) and 12 weeks |
| The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | 6 weeks (baseline) and 12 weeks |
| The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | 6 weeks (baseline) and 12 weeks |
| The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | 6 weeks (baseline) and 12 weeks |
| The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category. | Risk categories are: Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L Patients are defined as symptomatic if they meet at least 1 of the following criteria: History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg Total risk is derived from age, sex, TC, systolic BP and smoking status. | 6 weeks (baseline) and 12 weeks |
| Birmingham |
| United Kingdom |
| Research Site | Blackburn | United Kingdom |
| Research Site | Bolton | United Kingdom |
| Research Site | Crawley | United Kingdom |
| Research SIte | Glasgow | United Kingdom |
| Research Site | Newcastle | United Kingdom |
| Research SIte | Sheffield | United Kingdom |
| Research SIte | Slough | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rosuvastatin | rosuvastatin 5 mg |
| BG001 | Atorvastatin | atorvastatin 10 mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C) | Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100 | Intention to treat (ITT) population (all randomized patients). | Posted | Number | Percent Change in LDL-C | 6 weeks (baseline) and 12 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L | Intention to treat (ITT) population (all randomized patients). | Posted | Number | Percentage of Participants | 6 weeks (Baseline) and 12 weeks |
|
| |||||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L | Intention to treat (ITT) population (all randomized patients). | Posted | Number | Percentage of Participants | 6 weeks (baseline) and 12 weeks |
|
| |||||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category, and the Combined LDL-C and TC Target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, Both Depending on Risk Category. | Risk categories are: Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L Patients are defined as symptomatic if they meet at least 1 of the following criteria: History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg Total risk is derived from age, sex, TC, systolic BP and smoking status. | Intention to treat (ITT) population (all randomized patients). | Posted | Number | Percentage of Participants | 6 weeks (baseline) and 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Percentage Change From Baseline(week6) in TC | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | Intention to treat (ITT) population (all randomized patients). | Posted | Number | Percent Change in TC | 6 weeks (baseline) and 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C) | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | Intention to treat (ITT) population (all randomized patients). | Posted | Number | Percent Change in HDL-C | 6 weeks (baseline) and 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L | Intention to treat (ITT) population (all randomized patients). | Posted | Number | Percentage of Participants | 6 weeks (baseline) and 12 weeks |
|
| |||||||||||||||||||||||||||||||
| Secondary | The Percentage Change From Baseline (Week 6)in Non-HDL-C | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | Intention to treat (ITT) population (all randomized patients). | Posted | Number | Percent Change in Non-HDL-C | 6 weeks (baseline) and 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB) | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | Intention to treat (ITT) population (all randomized patients). | Posted | Number | Percent Change in ApoB | 6 weeks (baseline) and 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1) | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | Intention to treat (ITT) population (all randomized patients). | Posted | Number | Percent Change in ApoA1 | 6 weeks (baseline) and 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | Intention to treat (ITT) population (all randomized patients). | Posted | Number | Percent Change in LDL-C/HDL-C Ratio | 6 weeks (baseline) and 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | Intention to treat (ITT) population (all randomized patients). | Posted | Number | Percent Change in TC/HDL-C Ratio | 6 weeks (baseline) and 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | Intention to treat (ITT) population (all randomized patients). | Posted | Number | Percent Change in Non-HDL-C/HDL-C Ratio | 6 weeks (baseline) and 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio | Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 | Intention to treat (ITT) population (all randomized patients). | Posted | Number | Percent Change in ApoB/ApoA1 Ratio | 6 weeks (baseline) and 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category. | Risk categories are: Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L Patients are defined as symptomatic if they meet at least 1 of the following criteria: History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg Total risk is derived from age, sex, TC, systolic BP and smoking status. | Intention to treat (ITT) population (all randomized patients). | Posted | Number | Percentage of Participants | 6 weeks (baseline) and 12 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rosuvastatin | rosuvastatin 5 mg | 1 | 4 | ||||
| EG001 | Atorvastatin | atorvastatin 10 mg | 0 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular Accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
The study achieved only 8% of the randomised target number of patients and for this reason alone was terminated early. Planned statistical analyses could not be performed. No scientifically valid conclusions can be drawn from the limited study data.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | Astrazeneca | AZTrial_Results_Posting@astrazeneca.com |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| D000068718 | Rosuvastatin Calcium |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|