Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients

NCT00631189 | Completed Phase 4 Results

• 2 other identifiers: D3560L00068EudraCT No 2006-006697-15
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 170

Brief Summary

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.

Conditions

Type IIa and IIb Hypercholesterolaemia

Keywords

dyslipidemia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 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

• 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

• Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment

  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

  After 8 weeks of treatment

• Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks

  Baseline and after 8 weeks of treatment

Study Arms (2)

1

ACTIVE COMPARATOR

Rosuvastatin and Pravastatin

Drug: Rosuvastatin; Drug: Pravastatin

2

ACTIVE COMPARATOR

Rosuvastatin and Atorvastatin

Drug: Rosuvastatin; Drug: Atorvastatin

Interventions

Rosuvastatin DRUG

5mg oral

Also known as: Crestor

1; 2

Pravastatin DRUG

40mg oral

Also known as: Prevachol

1

Atorvastatin DRUG

10mg oral

Also known as: Lipitor

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects presenting type IIa or IIb primary hypercholesterolaemia diagnosed for at least 3 months, in a context of primary prevention with at least two associated cardiovascular risk factors and: (i)either "naive" to all lipid-lowering therapy, (ii)or treated with a statin (treatment ongoing or stopped during the previous 8 weeks)

You may not qualify if:

• homozygous or heterozygous familial hypercholesterolaemia
• hypertriglyceridaemia (TG ≥ 4 g/l)
• subjects at high cardiovascular risk according to the AFSSAPS 2005 definition (coronary artery disease or history of documented vascular disease, high cardiovascular risk type 2 diabetes, subject in primary prevention with a 10-year CHD risk \> 20%)
• history of adverse events or hypersensitivity to an HMG Co-A reductase inhibitor (particularly a history of myopathy)
• concomitant use of any drugs not authorized during the study
• active liver disease with elevation of serum transaminases (ASAT, ALAT) more than twice the upper limit of normal
• CPK more than 3 times the upper limit of normal
• moderate or severe renal failure (creatinine clearance \< 6 ml/min)
• poorly controlled hypothyroidism; poorly controlled hypertension (DBP \> 95 mm Hg and/or SBP \> 180 mm Hg)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (170)

Research Site

Aix-en-Provence, France

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Allaire, France

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Amiens, France

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Ancerville, France

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Angers, France

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Annecy, France

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Anzin, France

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Arles, France

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Arthez-de-Béarn, France

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Aspach-le-Bas, France

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Aubagne, France

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Auchel, France

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Bailleul, France

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Balma, France

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Beaucaire, France

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Belfort, France

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Bersée, France

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Bézenet, France

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Béziers, France

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Biarritz, France

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Blois, France

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Bondues, France

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Bondy, France

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Bordeaux, France

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Brignoud, France

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Bruay-la-Buissière, France

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Bruges, France

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Bœrsch, France

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Cabanac-et-Villagrains, France

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Cadaujac, France

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Caen, France

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Cannes La Bocca, France

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Carnon-Plage, France

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Caylus, France

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Cernay, France

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Cestas, France

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Champcueil, France

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Chanceaux-sur-Choisille, France

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Chilly-Mazarin, France

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Clary, France

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Collioure, France

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Colombier-Fontaine, France

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Colomiers, France

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Coulonieix Chamiers, France

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Crécy-la-Chapelle, France

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Crotenay, France

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Cuise-la-Motte, France

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Derval, France

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Dijon, France

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Eckbolsheim, France

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Eckwersheim, France

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Épernay, France

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Épinal, France

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Étang-sur-Arroux, France

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Évreux, France

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Fargues-Saint-Hilaire, France

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Folembray, France

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Fos-sur-Mer, France

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Franconville, France

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Gamarde-les-Bains, France

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Gambsheim, France

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Gradignan, France

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Grand-Couronne, France

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Grendelbruch, France

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Guise, France

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Harnes, France

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Horbourg-Wihr, France

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Is-sur-Tille, France

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Ivry-sur-Seine, France

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Jarville-la-Malgrange, France

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Jeumont, France

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La Ciotat, France

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La Courneuve, France

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La Crèche, France

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La Francheville, France

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Lacrouzette, France

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Lamagistère, France

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Laval, France

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Le Bouscat, France

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Le Cannet, France

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Le Passage, France

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Les Issambres, France

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Léognan, France

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Lille, France

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Lucheux, France

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Marcq-en-Barœul, France

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Marseille, France

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Maslacq, France

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Mauguio, France

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Meaux-beauval, France

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Mennecy, France

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Mensignac, France

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Merlimont, France

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Metz, France

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Miramont-de-Guyenne, France

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Mittersheim, France

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Monfort En Chalosse, France

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Monguilhem, France

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Mont-de-Marsan, France

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Montauroux, France

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Montbéliard, France

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Monteux, France

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Montfrin, France

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Montigny-lès-Metz, France

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Montpellier, France

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Moreuil, France

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Muespach, France

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Nancy, France

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Nogent-sur-Marne, France

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Noyon, France

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Oberhausbergen, France

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Orchamps, France

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Palau-del-Vidre, France

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Paris, France

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Pau, France

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Pauillac, France

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Périgueux, France

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Pfulgriesheim, France

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Phalempin, France

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Pont-à-Mousson, France

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Pouilly-en-Auxois, France

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Poussan, France

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Pradines, France

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Puteaux, France

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Quimperlé, France

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Rognac, France

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Rohrwiller, France

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Roncq, France

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Roquevaire, France

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Roubaix, France

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Saint-Etienne, France

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Saint-Émilion, France

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Saint-Étienne-de-Montluc, France

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Saint-Girons, France

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Saint-Jean-de-Braye, France

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Saint-Leu-la-Forêt, France

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Saint-Martin-d'Oney, France

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Saint-Médard-en-Jalles, France

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Saint-Morillon, France

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Saint-Rémy, France

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Saint-Rémy-de-Provence, France

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Salles, France

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Sarlat-la-Canéda, France

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Semur-en-Auxois, France

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Serres-Castet, France

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Soissons, France

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Sorcy-Saint-Martin, France

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Strasbourg, France

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Tarare, France

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Targon, France

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Tartas, France

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Tassin-la-Demi-Lune, France

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Thônes, France

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Thun-Saint-Amand, France

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Toulon, France

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Toulouse, France

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Trie-sur-Baïse, France

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Varces-Allières-et-Risset, France

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Vatan, France

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Vence, France

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Vélizy-Villacoublay, France

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Vieux-Boucau-les-Bains, France

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Villard-Bonnot, France

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Villette-d'Anthon, France

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Viry-Châtillon, France

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Wasselonne, France

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Wattignies, France

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Wattrelos, France

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Yerres, France

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Yffiniac, France

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MeSH Terms

Conditions

Dyslipidemias

Interventions

Rosuvastatin Calcium; Pravastatin; Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Limitations and Caveats

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.

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Michel Farnier, MD

  Le Point Medical - Rond Point du Jour

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: October 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 26, 2013
• Results First Posted: September 17, 2010

Record last verified: 2011-06

Locations

FR (170)