Cardiovascular Risk Assessment in Patients Treated With Caduet (RIGHT)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00297973
First received: February 27, 2006
Last updated: March 27, 2009
Last verified: April 2008
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Purpose
Compare the reduction in Framingham's predicted 10-year risk of a coronary event (6) in patients with hypertension and at least three other cardiovascular risk factors (including diabetic patients) seen in private practice and randomized to either Caduet or usual care.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Procedure: Blood pressure measurements Procedure: Blood samples |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Cardiovascular Risk Assessment In Patients With Hypertension And At Least Three Other Risk Factors, Treated With Caduet Compared To Usual Care: The Right Study |
Resource links provided by NLM:
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Caduet
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- % reduction in Framingham's predicted 10-year risk of a coronary event between V1 and V3 in the Caduet group compared to the usual care group (6) (including diabetic patients)
Secondary Outcome Measures:
- 1. % patients changing risk category between V1 and V3 2. % reduction in Framingham's predicted 10-year risk of a coronary event (8) excluding diabetic patients 3. Clinical and biological safety during treatment period
| Enrollment: | 1442 |
| Study Start Date: | February 2006 |
| Study Completion Date: | April 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 1.Male or female, 18 years of age or over, 2.Patient with hypertension and at least three other CV risk factors, 3.Hypertension, treated or not, but not at the currently recommended goals (140/90 mmHg for most patients, 130/80 mmHg for patients with diabetes or nephropathy). In case of treated hypertension, patients should be on their current treatment for at least 4 weeks before randomisation,
Exclusion Criteria:
- 1. Patient with a history of coronary heart disease, 2.Patients with a history of familial hypercholesterolemia, 3.Patient with malignant HTN, 4.Non-essential hypertension, 5.Known hypersensitivity to dihydropyridines, 6.Patients already receiving a dihydropyridine, 7.Known hypersensitivity to HMG-CoA-reductase inhibitors, 8.Patients currently receiving or who has received a HMG-CoA-reductase within the 3 months prior to selection, 9.Patients currently receiving or who has received a fibric acid, resins, ezetimibe, nicotinic acid and all other drug which is known to affect lipid levels, within 6 weeks prior to selection,
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297973
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| France | |
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| Abbeville, France, 80100 | |
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| Aire Sur La Lys, France, 62120 | |
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| Aix Les Bains, France, 73100 | |
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| Guise, France, 02120 | |
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| Ivry Sur Seine, France, 94200 | |
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| Jeumont Cedex, France, 59571 | |
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| L'Isle Sur La Sorgue, France, 84800 | |
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| La Baule, France, 44500 | |
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| La Chapelle Des Marais, France, 44410 | |
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| La Ciotat, France, 13600 | |
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| La Courneuve, France, 93120 | |
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| La Francheville, France, 08000 | |
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| La Grande Paroisse, France, 77130 | |
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| LA Rochelle, France, 17000 | |
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| St. Girons, France, 09200 | |
| Pfizer Investigational Site | |
| St. Jean De Braye, France, 45800 | |
| Pfizer Investigational Site | |
| St. Jean De Luz, France, 64500 | |
| Pfizer Investigational Site | |
| St. Jean De Maurienne, France, 73300 | |
| Pfizer Investigational Site | |
| St. Joachim, France, 44720 | |
| Pfizer Investigational Site | |
| St. Leu D'Esserent, France, 60340 | |
| Pfizer Investigational Site | |
| St. Leu La Foret, France, 95320 | |
| Pfizer Investigational Site | |
| St. Marcel Les Valence, France, 26320 | |
| Pfizer Investigational Site | |
| St. Martin D'Heres, France, 38400 | |
| Pfizer Investigational Site | |
| St. Martin Des Champs, France, 50300 | |
| Pfizer Investigational Site | |
| St. Martin Du Bois, France, 49500 | |
| Pfizer Investigational Site | |
| St. Morillon, France, 33650 | |
| Pfizer Investigational Site | |
| St. Ouen, France, 93400 | |
| Pfizer Investigational Site | |
| St. Ouen L'Aumone, France, 95310 | |
| Pfizer Investigational Site | |
| St. Rambert D'Albon, France, 26140 | |
| Pfizer Investigational Site | |
| St. Raphael, France, 83700 | |
| Pfizer Investigational Site | |
| St. Remy De Provence, France, 13210 | |
| Pfizer Investigational Site | |
| St. Saulve, France, 59880 | |
| Pfizer Investigational Site | |
| St. Sebastien Sur Loire, France, 44230 | |
| Pfizer Investigational Site | |
| St. Sulpice, France, 81370 | |
| Pfizer Investigational Site | |
| St. Tropez, France, 83990 | |
| Pfizer Investigational Site | |
| St. Yrieix La Perche, France, 87500 | |
| Pfizer Investigational Site | |
| Ste. Maxime, France, 83120 | |
| Pfizer Investigational Site | |
| Ste. Suzanne, France, 53270 | |
| Pfizer Investigational Site | |
| Strasbourg, France, 67200 | |
| Pfizer Investigational Site | |
| Strasbourg, France, 67000 | |
| Pfizer Investigational Site | |
| Suresnes, France, 92150 | |
| Pfizer Investigational Site | |
| Targon, France, 33760 | |
| Pfizer Investigational Site | |
| Tergnier, France, 02700 | |
| Pfizer Investigational Site | |
| Thiant, France, 59224 | |
| Pfizer Investigational Site | |
| Thierville Sur Meuse, France, 55840 | |
| Pfizer Investigational Site | |
| Thiviers, France, 24800 | |
| Pfizer Investigational Site | |
| Thones, France, 74230 | |
| Pfizer Investigational Site | |
| Toul, France, 54200 | |
| Pfizer Investigational Site | |
| Toulon, France, 83000 | |
| Pfizer Investigational Site | |
| Toulon, France, 83200 | |
| Pfizer Investigational Site | |
| Toulouse, France, 31500 | |
| Pfizer Investigational Site | |
| Toulouse, France, 31100 | |
| Pfizer Investigational Site | |
| Toulouse, France, 31200 | |
| Pfizer Investigational Site | |
| Toulouse, France, 31400 | |
| Pfizer Investigational Site | |
| Toulouse, France, 31000 | |
| Pfizer Investigational Site | |
| Tours, France, 37000 | |
| Pfizer Investigational Site | |
| Trie Sur Baise, France, 65220 | |
| Pfizer Investigational Site | |
| Vabres L'Abbaye, France, 12400 | |
| Pfizer Investigational Site | |
| Vacqueyras, France, 84190 | |
| Pfizer Investigational Site | |
| Vagney, France, 88120 | |
| Pfizer Investigational Site | |
| Valenciennes, France, 59300 | |
| Pfizer Investigational Site | |
| Valognes, France, 50700 | |
| Pfizer Investigational Site | |
| Valreas, France, 84600 | |
| Pfizer Investigational Site | |
| Vals Les Bains, France, 07600 | |
| Pfizer Investigational Site | |
| Vandoeuvre Les Nancy, France, 54500 | |
| Pfizer Investigational Site | |
| Vannes, France, 56000 | |
| Pfizer Investigational Site | |
| Varces Allieres Et Risset, France, 38760 | |
| Pfizer Investigational Site | |
| Vatan, France, 36150 | |
| Pfizer Investigational Site | |
| Velines, France, 24230 | |
| Pfizer Investigational Site | |
| Velizy Villacoublay, France, 78140 | |
| Pfizer Investigational Site | |
| Vence, France, 06140 | |
| Pfizer Investigational Site | |
| Venissieux, France, 69200 | |
| Pfizer Investigational Site | |
| Vernet, France, 31810 | |
| Pfizer Investigational Site | |
| Viane, France, 81530 | |
| Pfizer Investigational Site | |
| Villard Bonnot, France, 38190 | |
| Pfizer Investigational Site | |
| Villefranche de Rouergue, France, 12200 | |
| Pfizer Investigational Site | |
| Villefranche Sur Mer, France, 06230 | |
| Pfizer Investigational Site | |
| Villefranche Sur Saone, France, 69400 | |
| Pfizer Investigational Site | |
| Villeneuve Les Maguelone, France, 34750 | |
| Pfizer Investigational Site | |
| Villeparisis, France, 77270 | |
| Pfizer Investigational Site | |
| Villers St. Paul, France, 60870 | |
| Pfizer Investigational Site | |
| Villette D'Anthon, France, 38280 | |
| Pfizer Investigational Site | |
| Viry Chatillon, France, 91170 | |
| Pfizer Investigational Site | |
| Vitrolles, France, 13127 | |
| Pfizer Investigational Site | |
| Vix, France, 85770 | |
| Pfizer Investigational Site | |
| Wambrechies, France, 59118 | |
| Pfizer Investigational Site | |
| Wasselonne, France, 67310 | |
| Pfizer Investigational Site | |
| Wattignies, France, 59139 | |
| Pfizer Investigational Site | |
| Wattrelos, France, 59150 | |
| Pfizer Investigational Site | |
| Witry Les Reims, France, 51420 | |
| Pfizer Investigational Site | |
| Yffiniac, France, 22120 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00297973 History of Changes |
| Other Study ID Numbers: | A3841038 |
| Study First Received: | February 27, 2006 |
| Last Updated: | March 27, 2009 |
| Health Authority: | France: HAS - French Health Agency |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013