HypertensionPhase 4RIGHTNCT00297973

Cardiovascular Risk Assessment in Patients Treated With Caduet

A Phase 4 study testing Blood pressure measurements and Blood samples in people with Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 384 sites in France.

Completed

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

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Blood pressure measurements and Blood samples
Type of treatment: Surgery or procedure
How many people: 1,442 participants
Where: 384 sitesFrance
Study dates: Feb 2006to Apr 2007
Phase: Phase 4
Are there results?: None posted in the registry

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

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,

Who cannot join

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,

Trial locations and contacts

384 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

France300 sites

Pfizer Investigational Site
Abbeville, 80100
Pfizer Investigational Site
Aire-sur-la-Lys, 62120
Pfizer Investigational Site
Aix-les-Bains, 73100
Pfizer Investigational Site
Alençon, 61000
Pfizer Investigational Site
Allaire, 56350
Pfizer Investigational Site
Amboise, 37400
Pfizer Investigational Site
Amiens, 80000
Pfizer Investigational Site
Amiens, 80080
Pfizer Investigational Site
Amiens, 80094
Pfizer Investigational Site
Andrézieux-Bouthéon, 42160
Pfizer Investigational Site
Angers, 49000
Pfizer Investigational Site
Annecy, 74000
Pfizer Investigational Site
Annecy-le-Vieux, 74940
Pfizer Investigational Site
Annemasse, 74100
Pfizer Investigational Site
Anzin, 59410
Pfizer Investigational Site
Appoigny, 89380
Pfizer Investigational Site
Apt, 84400
Pfizer Investigational Site
Argenteuil, 95100
Pfizer Investigational Site
Arles, 13200
Pfizer Investigational Site
Arnèke, 59285
Pfizer Investigational Site
Arpajon, 91290
Pfizer Investigational Site
Arsac, 33460
Pfizer Investigational Site
Aubagne, 13400
Pfizer Investigational Site
Auchel, 62260
Pfizer Investigational Site
Audresselles, 62164
Pfizer Investigational Site
Autrans, 38880
Pfizer Investigational Site
Balma, 31130
Pfizer Investigational Site
Bastia, 20200
Pfizer Investigational Site
Bayonne, 64100
Pfizer Investigational Site
Beaucaire, 30300
Pfizer Investigational Site
Beaumont-lès-Valence, 26760
Pfizer Investigational Site
Beaurains, 62217
Pfizer Investigational Site
Beausoleil, 06240
Pfizer Investigational Site
Belley, 01300
Pfizer Investigational Site
Belpech, 11420
Pfizer Investigational Site
Benquet, 40280
Pfizer Investigational Site
Berck, 62600
Pfizer Investigational Site
Bersée, 59235
Pfizer Investigational Site
Béthune, 62400
Pfizer Investigational Site
Béziers, 34500
Pfizer Investigational Site
Biarritz, 64200
Pfizer Investigational Site
Blasimon, 33540
Pfizer Investigational Site
Blois, 41000
Pfizer Investigational Site
Boën-sur-Lignon, 42130
Pfizer Investigational Site
Bœrsch, 67530
Pfizer Investigational Site
Bondues, 59910
Pfizer Investigational Site
Bondy, 93140
Pfizer Investigational Site
Bordeaux, 33000
Pfizer Investigational Site
Bordeaux, 33200
Pfizer Investigational Site
Bourg-Saint-Andéol, 07700
Pfizer Investigational Site
Bourges, 18000
Pfizer Investigational Site
Bréhan, 56580
Pfizer Investigational Site
Brest, 29200
Pfizer Investigational Site
Brignoud, 38190
Pfizer Investigational Site
Bruay-la-Buissière, 62700
Pfizer Investigational Site
Cabestany, 66330
Pfizer Investigational Site
Caen, 14000
Pfizer Investigational Site
Cagnes-sur-Mer, 06800
Pfizer Investigational Site
Cannes, 06400
Pfizer Investigational Site
Cannes La Bocca, 06150
Pfizer Investigational Site
Carnon-Plage, 34280
Pfizer Investigational Site
Castelnau Le Fez, 34170
Pfizer Investigational Site
Castelsarrasin, 82100
Pfizer Investigational Site
Castres, 81100
Pfizer Investigational Site
Caylus, 82160
Pfizer Investigational Site
Cergy, 95000
Pfizer Investigational Site
Cestas, 33610
Pfizer Investigational Site
Champagne-au-Mont-d'Or, 69410
Pfizer Investigational Site
Chanceaux-sur-Choisille, 37390
Pfizer Investigational Site
Charleville-Mézières, 08000
Pfizer Investigational Site
Chartres, 28000
Pfizer Investigational Site
Chatou, 78400
Pfizer Investigational Site
Chelles, 77500
Pfizer Investigational Site
Chenôve, 21300
Pfizer Investigational Site
Chilly-Mazarin, 91380
Pfizer Investigational Site
Clairac, 47320
Pfizer Investigational Site
Clary, 59225
Pfizer Investigational Site
Clermont-Ferrand, 63100
Pfizer Investigational Site
Collioure, 66190
Pfizer Investigational Site
Colombier-Fontaine, 25260
Pfizer Investigational Site
Colomiers, 31770
Pfizer Investigational Site
Condat-sur-Vienne, 87920
Pfizer Investigational Site
Courthézon, 84350
Pfizer Investigational Site
Craponne, 69290
Pfizer Investigational Site
Crécy-la-Chapelle, 77580
Pfizer Investigational Site
Crest, 26400
Pfizer Investigational Site
Créteil, 94000
Pfizer Investigational Site
Crotenay, 39300
Pfizer Investigational Site
Cuise-la-Motte, 60350
Pfizer Investigational Site
Denain, 59220
Pfizer Investigational Site
Dijon, 21000
Pfizer Investigational Site
Dugny-sur-Meuse, 55100
Pfizer Investigational Site
Dunkirk, 59140
Pfizer Investigational Site
Échirolles, 38130
Pfizer Investigational Site
Eckbolsheim, 67201
Pfizer Investigational Site
Eckwersheim, 67550
Pfizer Investigational Site
Épernay, 51200
Pfizer Investigational Site
Épinal, 88000
Pfizer Investigational Site
Épinay-sur-Seine, 93800
Pfizer Investigational Site
Étampes, 91150
Pfizer Investigational Site
Étang-sur-Arroux, 71190
Pfizer Investigational Site
Évreux, 27000
Pfizer Investigational Site
Falaise, 14700
Pfizer Investigational Site
Fayence, 83440
Pfizer Investigational Site
Fenioux, 79160
Pfizer Investigational Site
Ferney-Voltaire, 01210
Pfizer Investigational Site
Floirac, 33270
Pfizer Investigational Site
Fontaine, 38600
Pfizer Investigational Site
Fontaine-lès-Dijon, 21121
Pfizer Investigational Site
Fontainebleau, 77300
Pfizer Investigational Site
Fontenay-sous-Bois, 94120
Pfizer Investigational Site
Fontès, 34320
Pfizer Investigational Site
Fos-sur-Mer, 13270
Pfizer Investigational Site
Franconville, 95130
Pfizer Investigational Site
Fumay, 08170
Pfizer Investigational Site
Gaillefontaine, 76870
Pfizer Investigational Site
Gambsheim, 67760
Pfizer Investigational Site
Gap, 05000
Pfizer Investigational Site
Gonesse, 95500
Pfizer Investigational Site
Gonneville-la-Mallet, 76280
Pfizer Investigational Site
Gradignan, 33170
Pfizer Investigational Site
Grand-Couronne, 76530
Pfizer Investigational Site
Gréasque, 13850
Pfizer Investigational Site
Grendelbruch, 67190
Pfizer Investigational Site
Grenoble, 38000
Pfizer Investigational Site
Grenoble, 38100
Pfizer Investigational Site
Groslay, 95410
Pfizer Investigational Site
Guise, 02120
Pfizer Investigational Site
Haguenau, 67500
Pfizer Investigational Site
Harnes, 62440
Pfizer Investigational Site
Hasparren, 64240
Pfizer Investigational Site
Hautmont, 59330
Pfizer Investigational Site
Hochfelden, 67270
Pfizer Investigational Site
Hostens, 33125
Pfizer Investigational Site
Ivry-sur-Seine, 94200
Pfizer Investigational Site
Jargeau, 45150
Pfizer Investigational Site
Jarville-la-Malgrange, 54140
Pfizer Investigational Site
Jeumont, 59460
Pfizer Investigational Site
Jeumont, 59571
Pfizer Investigational Site
L'Isle-sur-la-Sorgue, 84800
Pfizer Investigational Site
La Baule-Escoublac, 44500
Pfizer Investigational Site
La Chapelle-des-Marais, 44410
Pfizer Investigational Site
La Chapelle-sur-Erdre, 44240
Pfizer Investigational Site
La Ciotat, 13600
Pfizer Investigational Site
La Courneuve, 93120
Pfizer Investigational Site
La Crèche, 79260
Pfizer Investigational Site
La Fère, 02800
Pfizer Investigational Site
La Francheville, 08000
Pfizer Investigational Site
La Grande-Motte, 34280
Pfizer Investigational Site
La Grande-Paroisse, 77130
Pfizer Investigational Site
La Rochelle, 17000
Pfizer Investigational Site
La Tour-du-Crieu, 09100
Pfizer Investigational Site
La Trinité-sur-Mer, 56470
Pfizer Investigational Site
Labastidette, 31600
Pfizer Investigational Site
Lacrouzette, 81210
Pfizer Investigational Site
Lamagistère, 82360
Pfizer Investigational Site
Lamarque, 33460
Pfizer Investigational Site
Langon, 33210
Pfizer Investigational Site
Lattes, 34970
Pfizer Investigational Site
Laval, 53000
Pfizer Investigational Site
Lavernose-Lacasse, 31410
Pfizer Investigational Site
Laxou, 54520
Pfizer Investigational Site
Le Bourget, 93350
Pfizer Investigational Site
Le Cannet, 06110
Pfizer Investigational Site
Le Havre, 76600
Pfizer Investigational Site
Le Havre, 76610
Pfizer Investigational Site
Le Havre, 76620
Pfizer Investigational Site
Lembeye, 64350
Pfizer Investigational Site
Les Issambres, 83380
Pfizer Investigational Site
Les Sables-d'Olonne, 85100
Pfizer Investigational Site
Lesquin, 59810
Pfizer Investigational Site
Liancourt, 60140
Pfizer Investigational Site
Ligny-en-Barrois, 55500
Pfizer Investigational Site
Lille, 59000
Pfizer Investigational Site
Lille, 59800
Pfizer Investigational Site
Limoges, 87000
Pfizer Investigational Site
Lorient, 56100
Pfizer Investigational Site
Lourdes, 65100
Pfizer Investigational Site
Lucheux, 80600
Pfizer Investigational Site
Luxeuil-les-Bains, 70300
Pfizer Investigational Site
Lyon, 69008
Pfizer Investigational Site
Lyon, 69009
Pfizer Investigational Site
Mandelieu-la-Napoule, 06210
Pfizer Investigational Site
Marcq-en-Barœul, 59700
Pfizer Investigational Site
Marseille, 13002
Pfizer Investigational Site
Marseille, 13004
Pfizer Investigational Site
Marseille, 13006
Pfizer Investigational Site
Marseille, 13008
Pfizer Investigational Site
Marseille, 13009
Pfizer Investigational Site
Marseille, 13010
Pfizer Investigational Site
Marseille, 13012
Pfizer Investigational Site
Marseille, 13013
Pfizer Investigational Site
Marseille, 13015
Pfizer Investigational Site
Martigues, 13500
Pfizer Investigational Site
Masseret, 19510
Pfizer Investigational Site
Mauguio, 34130
Pfizer Investigational Site
Meaux Beauval, 77100
Pfizer Investigational Site
Meaux-Beauval, 77100
Pfizer Investigational Site
Mennecy, 91540
Pfizer Investigational Site
Mensignac, 24350
Pfizer Investigational Site
Merlimont, 62155
Pfizer Investigational Site
Metz, 57000
Pfizer Investigational Site
Mirabel-et-Blacons, 26400
Pfizer Investigational Site
Miramas, 13140
Pfizer Investigational Site
Miramas, 13141
Pfizer Investigational Site
Miramont-de-Guyenne, 47800
Pfizer Investigational Site
Mittersheim, 57930
Pfizer Investigational Site
Mommenheim, 67670
Pfizer Investigational Site
Mons-en-Barœul, 59370
Pfizer Investigational Site
Montauroux, 83440
Pfizer Investigational Site
Montbéliard, 25200
Pfizer Investigational Site
Monteux, 84170
Pfizer Investigational Site
Montpellier, 34000
Pfizer Investigational Site
Montpellier, 34070
Pfizer Investigational Site
Montreuil, 93100
Pfizer Investigational Site
Montrevel-en-Bresse, 01340
Pfizer Investigational Site
Moreuil, 80110
Pfizer Investigational Site
Morlaix, 29600
Pfizer Investigational Site
Mourenx, 64150
Pfizer Investigational Site
Muespach, 68640
Pfizer Investigational Site
Mulhouse, 68100
Pfizer Investigational Site
Mulhouse, 68200
Pfizer Investigational Site
Mundolsheim, 67450
Pfizer Investigational Site
Nancy, 54000
Pfizer Investigational Site
Nantes, 44000
Pfizer Investigational Site
Nantes, 44100
Pfizer Investigational Site
Nantes, 44200
Pfizer Investigational Site
Néris-les-Bains, 03310
Pfizer Investigational Site
Nevers, 58000
Pfizer Investigational Site
Nice, 06 000
Pfizer Investigational Site
Nice, 06000
Pfizer Investigational Site
Nice, 06200
Pfizer Investigational Site
Nice, 06300
Pfizer Investigational Site
Niort, 79000
Pfizer Investigational Site
Nogent-sur-Marne, 94130
Pfizer Investigational Site
Noisiel, 77186
Pfizer Investigational Site
Noyon, 60400
Pfizer Investigational Site
Oberhausbergen, 67205
Pfizer Investigational Site
Obernai, 67210
Pfizer Investigational Site
Objat, 19130
Pfizer Investigational Site
Orange, 84100
Pfizer Investigational Site
Orchamps, 39700
Pfizer Investigational Site
Orry-la-Ville, 60560
Pfizer Investigational Site
Ossès, 64780
Pfizer Investigational Site
Pacy-sur-Eure, 27210
Pfizer Investigational Site
Palau-del-Vidre, 66690
Pfizer Investigational Site
Paris, 75009
Pfizer Investigational Site
Paris, 75012
Pfizer Investigational Site
Paris, 75013
Pfizer Investigational Site
Paris, 75014
Pfizer Investigational Site
Paris, 75015
Pfizer Investigational Site
Paris, 75017
Pfizer Investigational Site
Paris, 75018
Pfizer Investigational Site
Paris, 75019
Pfizer Investigational Site
Paris, 75020
Pfizer Investigational Site
Paris, 75116
Pfizer Investigational Site
Paris 06 Luxembourg, 81370
Pfizer Investigational Site
Parthenay, 79200
Pfizer Investigational Site
Perpignan, 66100
Pfizer Investigational Site
Pessac, 33600
Pfizer Investigational Site
Petit-Couronne, 76650
Pfizer Investigational Site
Pfulgriesheim, 67370
Pfizer Investigational Site
Phalempin, 59133
Pfizer Investigational Site
Pont-à-Mousson, 54700
Pfizer Investigational Site
Portet-sur-Garonne, 31120
Pfizer Investigational Site
Porto-Vecchio, 20137
Pfizer Investigational Site
Poussan, 34560
Pfizer Investigational Site
Pradines, 46090
Pfizer Investigational Site
Précy-sur-Oise, 60460
Pfizer Investigational Site
Quimperlé, 29300
Pfizer Investigational Site
Rebais, 77510
Pfizer Investigational Site
Reims, 51100
Pfizer Investigational Site
Remiremont, 88200
Pfizer Investigational Site
Rennes, 35200
Pfizer Investigational Site
Rigney, 25640
Pfizer Investigational Site
Rodez, 12001
Pfizer Investigational Site
Rognac, 13340
Pfizer Investigational Site
Rohrwiller, 67410
Pfizer Investigational Site
Romans-sur-Isère, 26100
Pfizer Investigational Site
Roncq, 59223
Pfizer Investigational Site
Roquevaire, 13360
Pfizer Investigational Site
Roubaix, 59071
Pfizer Investigational Site
Roubaix, 59100
Pfizer Investigational Site
Rozay-en-Brie, 77540
Pfizer Investigational Site
Saint-Agrève, 07320
Pfizer Investigational Site
Saint-Avold, 57500
Pfizer Investigational Site
Saint-Brieuc, 22015
Pfizer Investigational Site
Saint-Denis, 93200
Pfizer Investigational Site
Saint-Dié, 88100
Pfizer Investigational Site
Saint-Erme-Outre-et-Ramecourt, 02820
Pfizer Investigational Site
Saint-Etienne, 42000
Pfizer Investigational Site
Saint-Etienne, 42100
Pfizer Investigational Site
Saint-Fons, 69190
Pfizer Investigational Site
Saint-Germain-au-Mont-d'Or, 69650
Pfizer Investigational Site
Saint-Germain-de-Marencennes, 17700
Pfizer Investigational Site
Saint-Girons, 09200
Pfizer Investigational Site
Saint-Jean-de-Braye, 45800
Pfizer Investigational Site
Saint-Jean-de-Luz, 64500
Pfizer Investigational Site
Saint-Jean-de-Maurienne, 73300
Pfizer Investigational Site
Saint-Joachim, 44720

Other trials in France

About this study

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

Conditions: Hypertension
Being tested: Blood pressure measurements, Blood samples
Medical subject headings: Hypertension

What participants receive

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

Blood pressure measurementsProcedure or surgery
Blood samplesProcedure or surgery

What is being measured

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

% 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 outcomes (1)

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

Timeline

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

Feb 2006Apr 2007

First posted1 Mar 2006 (estimated)
Study startFeb 2006
Study completionApr 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,442 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00297973
Sponsor's protocol ID: A3841038
Acronym: RIGHT
Status last verified: Jan 2021
First submitted: 27 Feb 2006
Last updated: 27 Jan 2021
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00297973
Acronym / sponsor ID: RIGHT / A3841038
Conditions: Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,442 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Feb 2006
Study completion: Apr 2007 (actual)
First posted: 1 Mar 2006 (estimated)
Results: Not posted in the source record

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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

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

Key inclusion criteria (1 listed)

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,

Key exclusion criteria (1 listed)

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,

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
Blood pressure measurements	Procedure or surgery	–
Blood samples	Procedure or surgery	–

Primary outcome

% 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)

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

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.

Pfizer CT.gov Call Center study director

Pfizer

384 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 Blood pressure measurements and Blood samples in people with Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 384 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 1 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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 384 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

% 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). 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 NCT00297973.

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 27 Jan 2021.