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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No 2006-006697-15 |
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The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and Atorvastatin 10 mg. Treatment efficacy will be evaluated by the percentage of LDL-C variation after 8 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Rosuvastatin and Pravastatin |
|
| 2 | Active Comparator | Rosuvastatin and Atorvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 5mg oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks | To compare the percentages of LDL-C level variation. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | Change from baseline and after 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To Compare the Percentage of Patients Reaching the Overall LDL-C Goal According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients | Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Farnier, MD | Le Point Medical - Rond Point du Jour | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aix-en-Provence | France | ||||
| Research Site |
This French multicentre, randomized double-blind study was conducted on three parallel arms. The 14-week study comprised 3 visits: a screening visit (week 0, V1), a randomization and treatment allocation visit (week 6, V2) and an evaluation visit (week 14, V3). Patients were randomized at V2 and were treated for a period of 8 weeks.
Patients were recruited by general practitioner. First patient included: 12 October 2007 Last patient terminated the study: 04 October 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Initial Phase | Initial phase (between V1 and V2) |
| FG001 | Atorvastatin | Atorvastatin 10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Phase |
|
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| Pravastatin | Drug | 40mg oral |
|
|
| Atorvastatin | Drug | 10mg oral |
|
|
| Not done |
| To Compare the Percentage of Patients Reaching the LDL-C Goal, in Relation to the Number of Risk Factors, According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients | Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | Not done |
| Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment | To compare the percentage of total cholesterol variation taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | from baseline and after 8 weeks of treatment |
| Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment | Compare the percentage of HDL-C (High Density Lipoprotein Cholesterol) variation taking baseline value as a reference and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | After 8 weeks of treatment |
| Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks | To compare the percentage of variation from baseline triglycerides values and after 8 weeks. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | Baseline and after 8 weeks of treatment |
| Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment | To Compare the percentage of variation from baseline Apolipoprotein B/Apolipoprotein A1 ratio and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | baseline and after 8 weeks of treatment |
| Compare the Percentage of Variation of C-reactive Protein (CRP) | To compare the percentage of variation of C-reactive protein (CRP) taking baseline values as reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | baseline and after 8 weeks of treatment |
| Compare the Percentage of Variation of Phospholipase A2 (PLA2) | To Compare the percentage of variation of phospholipase A2 (PLA2) taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | from baseline and after 8 weeks of treatment |
| Compare the Numbers of Patients Achieving the LDL-C Goal According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP) ATP III) Guidelines for the Management of Dyslipidaemic Patients | To Compare numbers of patients achieving the LDL-C goal according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP). As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data. The percentage of patients achieving the NCEP-ATP III LDL-C goal. ATP III is categorized into 3 risk categories:(1) established CHD and CHD risk equivalents(2) multiple risk factors(3) zero to one (0-1) risk factor | from baseline and after 8 weeks of treatment |
| Compare the Numbers of Patients Achieving the LDL-C Goal According to the European Atherosclerosis Society (EAS) Guidelines for the Management of Dyslipidaemic Patients | Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data. |
| To Evaluate Clinical and Laboratory Safety | Serious Adverse Event and Adverse Event reported throughout the study | duration of study |
| Allaire |
| France |
| Research Site | Amiens | France |
| Research Site | Ancerville | France |
| Research Site | Angers | France |
| Research Site | Annecy | France |
| Research Site | Anzin | France |
| Research Site | Arles | France |
| Research Site | Arthez-de-Béarn | France |
| Research Site | Aspach-le-Bas | France |
| Research Site | Aubagne | France |
| Research Site | Auchel | France |
| Research Site | Bailleul | France |
| Research Site | Balma | France |
| Research Site | Beaucaire | France |
| Research Site | Belfort | France |
| Research Site | Bersée | France |
| Research Site | Bézenet | France |
| Research Site | Béziers | France |
| Research Site | Biarritz | France |
| Research Site | Blois | France |
| Research Site | Bondues | France |
| Research Site | Bondy | France |
| Research Site | Bordeaux | France |
| Research Site | Brignoud | France |
| Research Site | Bruay-la-Buissière | France |
| Research Site | Bruges | France |
| Research Site | Bœrsch | France |
| Research Site | Cabanac-et-Villagrains | France |
| Research Site | Cadaujac | France |
| Research Site | Caen | France |
| Research Site | Cannes La Bocca | France |
| Research Site | Carnon-Plage | France |
| Research Site | Caylus | France |
| Research Site | Cernay | France |
| Research Site | Cestas | France |
| Research Site | Champcueil | France |
| Research Site | Chanceaux-sur-Choisille | France |
| Research Site | Chilly-Mazarin | France |
| Research Site | Clary | France |
| Research Site | Collioure | France |
| Research Site | Colombier-Fontaine | France |
| Research Site | Colomiers | France |
| Research Site | Coulonieix Chamiers | France |
| Research Site | Crécy-la-Chapelle | France |
| Research Site | Crotenay | France |
| Research Site | Cuise-la-Motte | France |
| Research Site | Derval | France |
| Research Site | Dijon | France |
| Research Site | Eckbolsheim | France |
| Research Site | Eckwersheim | France |
| Research Site | Épernay | France |
| Research Site | Épinal | France |
| Research Site | Étang-sur-Arroux | France |
| Research Site | Évreux | France |
| Research Site | Fargues-Saint-Hilaire | France |
| Research Site | Folembray | France |
| Research Site | Fos-sur-Mer | France |
| Research Site | Franconville | France |
| Research Site | Gamarde-les-Bains | France |
| Research Site | Gambsheim | France |
| Research Site | Gradignan | France |
| Research Site | Grand-Couronne | France |
| Research Site | Grendelbruch | France |
| Research Site | Guise | France |
| Research Site | Harnes | France |
| Research Site | Horbourg-Wihr | France |
| Research Site | Is-sur-Tille | France |
| Research Site | Ivry-sur-Seine | France |
| Research Site | Jarville-la-Malgrange | France |
| Research Site | Jeumont | France |
| Research Site | La Ciotat | France |
| Research Site | La Courneuve | France |
| Research Site | La Crèche | France |
| Research Site | La Francheville | France |
| Research Site | Lacrouzette | France |
| Research Site | Lamagistère | France |
| Research Site | Laval | France |
| Research Site | Le Bouscat | France |
| Research Site | Le Cannet | France |
| Research Site | Le Passage | France |
| Research Site | Les Issambres | France |
| Research Site | Léognan | France |
| Research Site | Lille | France |
| Research Site | Lucheux | France |
| Research Site | Marcq-en-Barœul | France |
| Research Site | Marseille | France |
| Research Site | Maslacq | France |
| Research Site | Mauguio | France |
| Research Site | Meaux-beauval | France |
| Research Site | Mennecy | France |
| Research Site | Mensignac | France |
| Research Site | Merlimont | France |
| Research Site | Metz | France |
| Research Site | Miramont-de-Guyenne | France |
| Research Site | Mittersheim | France |
| Research Site | Monfort En Chalosse | France |
| Research Site | Monguilhem | France |
| Research Site | Mont-de-Marsan | France |
| Research Site | Montauroux | France |
| Research Site | Montbéliard | France |
| Research Site | Monteux | France |
| Research Site | Montfrin | France |
| Research Site | Montigny-lès-Metz | France |
| Research Site | Montpellier | France |
| Research Site | Moreuil | France |
| Research Site | Muespach | France |
| Research Site | Nancy | France |
| Research Site | Nogent-sur-Marne | France |
| Research Site | Noyon | France |
| Research Site | Oberhausbergen | France |
| Research Site | Orchamps | France |
| Research Site | Palau-del-Vidre | France |
| Research Site | Paris | France |
| Research Site | Pau | France |
| Research Site | Pauillac | France |
| Research Site | Périgueux | France |
| Research Site | Pfulgriesheim | France |
| Research Site | Phalempin | France |
| Research Site | Pont-à-Mousson | France |
| Research Site | Pouilly-en-Auxois | France |
| Research Site | Poussan | France |
| Research Site | Pradines | France |
| Research Site | Puteaux | France |
| Research Site | Quimperlé | France |
| Research Site | Rognac | France |
| Research Site | Rohrwiller | France |
| Research Site | Roncq | France |
| Research Site | Roquevaire | France |
| Research Site | Roubaix | France |
| Research Site | Saint-Etienne | France |
| Research Site | Saint-Émilion | France |
| Research Site | Saint-Étienne-de-Montluc | France |
| Research Site | Saint-Girons | France |
| Research Site | Saint-Jean-de-Braye | France |
| Research Site | Saint-Leu-la-Forêt | France |
| Research Site | Saint-Martin-d'Oney | France |
| Research Site | Saint-Médard-en-Jalles | France |
| Research Site | Saint-Morillon | France |
| Research Site | Saint-Rémy | France |
| Research Site | Saint-Rémy-de-Provence | France |
| Research Site | Salles | France |
| Research Site | Sarlat-la-Canéda | France |
| Research Site | Semur-en-Auxois | France |
| Research Site | Serres-Castet | France |
| Research Site | Soissons | France |
| Research Site | Sorcy-Saint-Martin | France |
| Research Site | Strasbourg | France |
| Research Site | Tarare | France |
| Research Site | Targon | France |
| Research Site | Tartas | France |
| Research Site | Tassin-la-Demi-Lune | France |
| Research Site | Thônes | France |
| Research Site | Thun-Saint-Amand | France |
| Research Site | Toulon | France |
| Research Site | Toulouse | France |
| Research Site | Trie-sur-Baïse | France |
| Research Site | Varces-Allières-et-Risset | France |
| Research Site | Vatan | France |
| Research Site | Vence | France |
| Research Site | Vélizy-Villacoublay | France |
| Research Site | Vieux-Boucau-les-Bains | France |
| Research Site | Villard-Bonnot | France |
| Research Site | Villette-d'Anthon | France |
| Research Site | Viry-Châtillon | France |
| Research Site | Wasselonne | France |
| Research Site | Wattignies | France |
| Research Site | Wattrelos | France |
| Research Site | Yerres | France |
| Research Site | Yffiniac | France |
| FG002 |
| Pravastatin |
Pravastatin 40 mg |
| FG003 | Rosuvastatin | Rosuvastatin 5 mg |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Treatment Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Initial Phase | Initial phase (between V1 and V2) |
| BG001 | Atorvastatin | Atorvastatin 10 mg |
| BG002 | Pravastatin | Pravastatin 40 mg |
| BG003 | Rosuvastatin | Rosuvastatin 5 mg |
| BG004 | 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 |
| |||||||||||||||
| Gender | Number | 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 | Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks | To compare the percentages of LDL-C level variation. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | 92 patients completed the study in the Pravastatin group, nevertheless, primary and secondary outcome measures are described on 91 patients in the Pravastatin arm due to one missing data in this group | Posted | Mean | Standard Deviation | percentage of LDL-C decrease | Change from baseline and after 8 weeks of treatment |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | To Compare the Percentage of Patients Reaching the Overall LDL-C Goal According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients | Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | Not Posted | Not done | |||||||||||||||||||||||||||||||||||||||||
| Secondary | To Compare the Percentage of Patients Reaching the LDL-C Goal, in Relation to the Number of Risk Factors, According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients | Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | Not Posted | Not done | |||||||||||||||||||||||||||||||||||||||||
| Secondary | Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment | To compare the percentage of total cholesterol variation taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | Posted | Mean | Standard Deviation | percentage of total cholesterol decrease | from baseline and after 8 weeks of treatment |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment | Compare the percentage of HDL-C (High Density Lipoprotein Cholesterol) variation taking baseline value as a reference and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | Posted | Mean | Standard Deviation | percentage of HDL-C increase | After 8 weeks of treatment |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks | To compare the percentage of variation from baseline triglycerides values and after 8 weeks. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | Posted | Mean | Standard Deviation | percentage of triglycerides decrease | Baseline and after 8 weeks of treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment | To Compare the percentage of variation from baseline Apolipoprotein B/Apolipoprotein A1 ratio and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | Posted | Mean | Standard Deviation | percent. Apolipoprotein B/A1 decrease | baseline and after 8 weeks of treatment |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Compare the Percentage of Variation of C-reactive Protein (CRP) | To compare the percentage of variation of C-reactive protein (CRP) taking baseline values as reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | Posted | Mean | Standard Deviation | percent of variation of C-reactive prot. | baseline and after 8 weeks of treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Compare the Percentage of Variation of Phospholipase A2 (PLA2) | To Compare the percentage of variation of phospholipase A2 (PLA2) taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data | Posted | Mean | Standard Deviation | percent of variation of phospholipase A2 | from baseline and after 8 weeks of treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Compare the Numbers of Patients Achieving the LDL-C Goal According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP) ATP III) Guidelines for the Management of Dyslipidaemic Patients | To Compare numbers of patients achieving the LDL-C goal according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP). As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data. The percentage of patients achieving the NCEP-ATP III LDL-C goal. ATP III is categorized into 3 risk categories:(1) established CHD and CHD risk equivalents(2) multiple risk factors(3) zero to one (0-1) risk factor | Posted | Number | Participants | from baseline and after 8 weeks of treatment |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Compare the Numbers of Patients Achieving the LDL-C Goal According to the European Atherosclerosis Society (EAS) Guidelines for the Management of Dyslipidaemic Patients | Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data. | Not Posted | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | To Evaluate Clinical and Laboratory Safety | Serious Adverse Event and Adverse Event reported throughout the study | Posted | Number | Adverse Events | duration of study |
|
|
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 | Initial Phase | Initial phase (between V1 and V2) | 2 | 317 | 6 | 317 | ||
| EG001 | Atorvastatin | Atorvastatin 10 mg | 4 | 97 | 5 | 97 | ||
| EG002 | Pravastatin | Pravastatin 40 mg | 1 | 92 | 7 | 92 | ||
| EG003 | Rosuvastatin | Rosuvastatin 5 mg | 0 | 103 | 5 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coxarthrosisaggravation | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Benign prostatic nodular hyperplasia | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Carotid thrombosis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Left Lumbar Cruralgia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VIiolent abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Worsening of gonalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Morton syndrome | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| gingival hypoplasia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| hypersensitivity | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Morton's neuralgia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| abdominal distension | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| visual impairment | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Laryngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| venous insufficiency | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| knee arthroplasty joint prosthesis user | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ear Infection | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| fungal infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| lung infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| vaginal infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data.
If the PI wants to discuss or publish results after the trial is completed he must obtain writing authorization from AstraZeneca
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D017035 | Pravastatin |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| 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 |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided
| Protocol Violation |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Pregnancy |
|
| patient did not take pravastatin |
|
| Male |
|
| Units |
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| Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Counts |
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| Participants |
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| Units | Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
Rosuvastatin 5 mg |
|
|
|