Type IIa and IIb HypercholesterolaemiaPhase 4CAP-CholNCT00631189

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

A Phase 4 study testing Rosuvastatin, Pravastatin and Atorvastatin in people with Type IIa and IIb Hypercholesterolaemia, run by AstraZeneca at 170 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type IIa and IIb Hypercholesterolaemia
What is being tested?: Rosuvastatin, Pravastatin and Atorvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 668 participants
Where: 170 sitesFrance
Study dates: Oct 2007to Oct 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 9Show fewer

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)

Trial locations and contacts

170 sites in 1 country.

City, postcode or hospital

170 sites in 1 country

France170 sites

Research Site
Aix-en-Provence
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Allaire
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Amiens
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Ancerville
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Angers
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Annecy
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Anzin
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Arles
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Arthez-de-Béarn
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Aspach-le-Bas
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Aubagne
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Auchel
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Bailleul
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Balma
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Beaucaire
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Belfort
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Bersée
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Bézenet
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Béziers
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Biarritz
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Blois
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Bœrsch
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Bondues
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Bondy
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Bordeaux
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Brignoud
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Bruay-la-Buissière
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Bruges
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Cabanac-et-Villagrains
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Cadaujac
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Caen
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Cannes La Bocca
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Carnon-Plage
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Caylus
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Cernay
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Cestas
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Champcueil
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Chanceaux-sur-Choisille
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Chilly-Mazarin
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Clary
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Collioure
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Colombier-Fontaine
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Colomiers
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Coulonieix Chamiers
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Crécy-la-Chapelle
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Crotenay
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Cuise-la-Motte
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Derval
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Dijon
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Eckbolsheim
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Eckwersheim
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Épernay
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Épinal
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Étang-sur-Arroux
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Évreux
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Fargues-Saint-Hilaire
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Folembray
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Fos-sur-Mer
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Franconville
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Gamarde-les-Bains
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Gambsheim
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Gradignan
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Grand-Couronne
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Grendelbruch
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Guise
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Harnes
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Horbourg-Wihr
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Is-sur-Tille
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Ivry-sur-Seine
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Jarville-la-Malgrange
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Jeumont
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La Ciotat
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La Courneuve
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La Crèche
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La Francheville
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Lacrouzette
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Lamagistère
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Laval
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Le Bouscat
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Le Cannet
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Le Passage
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Léognan
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Les Issambres
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Lille
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Lucheux
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Marcq-en-Barœul
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Marseille
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Maslacq
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Mauguio
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Meaux-beauval
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Mennecy
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Mensignac
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Merlimont
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Metz
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Miramont-de-Guyenne
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Mittersheim
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Monfort En Chalosse
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Monguilhem
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Mont-de-Marsan
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Montauroux
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Montbéliard
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Monteux
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Montfrin
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Montigny-lès-Metz
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Montpellier
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Moreuil
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Muespach
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Nancy
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Nogent-sur-Marne
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Noyon
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Oberhausbergen
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Orchamps
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Palau-del-Vidre
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Paris
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Pau
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Pauillac
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Périgueux
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Pfulgriesheim
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Phalempin
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Pont-à-Mousson
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Pouilly-en-Auxois
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Poussan
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Pradines
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Puteaux
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Quimperlé
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Rognac
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Rohrwiller
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Roncq
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Roquevaire
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Roubaix
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Saint-Émilion
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Saint-Etienne
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Saint-Étienne-de-Montluc
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Saint-Girons
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Saint-Jean-de-Braye
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Saint-Leu-la-Forêt
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Saint-Martin-d'Oney
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Saint-Médard-en-Jalles
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Saint-Morillon
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Saint-Rémy
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Saint-Rémy-de-Provence
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Salles
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Sarlat-la-Canéda
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Semur-en-Auxois
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Serres-Castet
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Soissons
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Sorcy-Saint-Martin
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Strasbourg
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Tarare
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Targon
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Tartas
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Tassin-la-Demi-Lune
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Thônes
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Thun-Saint-Amand
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Toulon
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Toulouse
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Trie-sur-Baïse
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Varces-Allières-et-Risset
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Vatan
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Vélizy-Villacoublay
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Vence
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Vieux-Boucau-les-Bains
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Villard-Bonnot
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Villette-d'Anthon
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Viry-Châtillon
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Wasselonne
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Wattignies
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Wattrelos
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Yerres
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Yffiniac

Other trials in France

About this study

Official title: Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Subjects With Type IIa and IIb Hypercholesterolaemia

Conditions: Type IIa and IIb Hypercholesterolaemia
Being tested: Rosuvastatin, Pravastatin, Atorvastatin
Keywords: dyslipidemia
Medical subject headings: Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RosuvastatinDrug
Also called Crestor
5mg oral
PravastatinDrug
Also called Prevachol
40mg oral
AtorvastatinDrug
Also called Lipitor
10mg oral

Study groups in NCT00631189
Study group	Role	What they receive
1	Active comparator	Rosuvastatin and Pravastatin Receives: Drug: Rosuvastatin; Drug: Pravastatin
2	Active comparator	Rosuvastatin and Atorvastatin Receives: Drug: Rosuvastatin; Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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. 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: duration of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Oct 2008

First posted7 Mar 2008 (estimated)
Study startOct 2007
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type IIa and IIb HypercholesterolaemiaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 668 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00631189
Sponsor's protocol ID: D3560L00068
Other IDs: EudraCT No 2006-006697-15
Acronym: CAP-Chol
Status last verified: Jun 2011
First submitted: 28 Feb 2008
Last updated: 26 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Subjects With Type IIa and IIb Hypercholesterolaemia
ClinicalTrials.gov ID: NCT00631189
Acronym / sponsor ID: CAP-Chol / D3560L00068
Conditions: Type IIa and IIb Hypercholesterolaemia
Keywords: dyslipidemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 668 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 7 Mar 2008 (estimated)
Results: Posted 17 Sep 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: Rosuvastatin, Drug: PravastatinRosuvastatin and Pravastatin
2	Active comparator	Drug: Rosuvastatin, Drug: AtorvastatinRosuvastatin and Atorvastatin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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)

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RosuvastatinAlso: Crestor5mg oral	Drug	1, 2
PravastatinAlso: Prevachol40mg oral	Drug	1
AtorvastatinAlso: Lipitor10mg oral	Drug	2

Primary outcome

Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks
Time frame: Change from baseline and after 8 weeks of treatment
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

11 secondary outcomes

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
Time frame: 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
Time frame: Not done
Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment
Time frame: 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
Time frame: After 8 weeks of treatment
Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks
Time frame: 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
Time frame: baseline and after 8 weeks of treatment
Compare the Percentage of Variation of C-reactive Protein (CRP)
Time frame: baseline and after 8 weeks of treatment
Compare the Percentage of Variation of Phospholipase A2 (PLA2)
Time frame: 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
Time frame: 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
To Evaluate Clinical and Laboratory Safety
Time frame: duration of study

Results and safety

Results posted to the registry on 17 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Initial Phase	668	317
Atorvastatin	0	0
Pravastatin	0	0
Rosuvastatin	0	0

Primary outcome: Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks

Time frame: Change from baseline and after 8 weeks of treatment. Mean (Standard Deviation). Unit: percentage of LDL-C decrease

Measure	Initial Phase n = 0	Atorvastatin n = 97	Pravastatin n = 91	Rosuvastatin n = 103
Value	–	-39.4 (13.77)	-30.3 (15.43)	-37.6 (17.96)

Population analysed: 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

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Initial Phase	2 of 317 (0.6%)	6 of 317 (1.9%)	Not reported
Atorvastatin	4 of 97 (4.1%)	5 of 97 (5.2%)	Not reported
Pravastatin	1 of 92 (1.1%)	7 of 92 (7.6%)	Not reported
Rosuvastatin	0 of 103 (0%)	5 of 103 (4.9%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michel Farnier, MD principal investigator

Le Point Medical - Rond Point du Jour

170 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rosuvastatin, Pravastatin and Atorvastatin in people with Type IIa and IIb Hypercholesterolaemia, run by AstraZeneca at 170 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks (time frame: Change from baseline and after 8 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00631189.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013.