Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension
NCT ID: NCT00311155
Last Updated: 2010-12-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
694 participants
INTERVENTIONAL
2006-03-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Olmesartan medoxomil oral tablets for 4 weeks followed by, if necessary:
Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets for 8 weeks, followed by, if necessary:
Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets + amlodipine oral tablets for 8 weeks
olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary
Olmesartan medoxomil oral tablets 20 mg for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 12.5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 10 mg for 4 weeks. All study medications are to be taken once daily. The subject's participation completes when blood pressure goals are achieved.
Interventions
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olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary
Olmesartan medoxomil oral tablets 20 mg for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 12.5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 10 mg for 4 weeks. All study medications are to be taken once daily. The subject's participation completes when blood pressure goals are achieved.
Eligibility Criteria
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Inclusion Criteria
* Pre-treated patients with normal or elevated blood pressure (BP) are eligible to participate if their pre-treatment medication can be withdrawn. At the end of the placebo run-in period sitting systolic BP greater than or equal to 140 and less than 180 mmHg and/or sitting diastolic BP greater than or equal to 90 and less than 110 mmHg at trough.
Exclusion Criteria
* Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cardiovascular, renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/oncological, neurological and psychiatric diseases.
* Patients within the last 6 months having a history of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, cerebrovascular accident, or transient ischemic attack.
* Patients with clinically significant elevations in laboratory values at Screening Visit.
* Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome.
* Patients with contraindications for olmesartan medoxomil, hydrochlorothiazide, and/or amlodipine besylate.
18 Years
ALL
No
Sponsors
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Sankyo Pharma Gmbh
INDUSTRY
Responsible Party
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Daiichi Sankyo Europe, GmbH
Principal Investigators
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Anthony Heagerty, MD
Role: PRINCIPAL_INVESTIGATOR
University of Manchester, Dept. of Medicine
Locations
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Fulpmes, , Austria
University Klinik, F. Innere Medizin
Innsbruck, , Austria
Innsbruck, , Austria
Kundl, , Austria
Salzburg, , Austria
Diakonissen-Krankenhaus Hospital
Salzburg-Aigen, , Austria
Brussels, , Belgium
Mechelen, , Belgium
Centre Hospitalier du Bois de l'Abbaye et de Hesba, Department of Intensive Care
Seraing, , Belgium
Allgemeen Ziekenhuis Maria-Middelares, Cardiologie, Campus de Pelikaan
Temse, , Belgium
Ancerville, , France
Bourges, , France
Derval, , France
Grenoble, , France
Lille, , France
Montrevel-en-Bresse, , France
Pouilly-en-Auxois, , France
Poussan, , France
Saint-Aubin-des-Châteaux, , France
Saint-Étienne-de-Montluc, , France
Saint-Priest, , France
Sorcy-Saint-Martin, , France
Strasbourg, , France
Yerres, , France
Annweiler am Trifels, , Germany
Balve, , Germany
Bammental, , Germany
Ev. Krankenhaus Bielefeld, Medizinische Klinik in Bethel - Gilead I
Bielefeld, , Germany
Uniklinik Bonn
Bonn, , Germany
Goch, , Germany
Haag, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Heidelberg (Neuenheim), , Germany
Mühldorf / Inn, , Germany
Schwenningen, , Germany
VS-Villingen, , Germany
Weyhe, , Germany
Ospedale Regina Apostolorum
Albano Laziale (RM), , Italy
Ospedale C.G. Mazzoni
Ascoli Piceno, , Italy
Ospedale Nuovo Cutroni
Barcellona Pozzo Di Gotto (ME), , Italy
Casa di Cura "La Madonnina"
Bari, , Italy
Ospedale San Sebastiano
Caserta, , Italy
Ospedale Vittorio Emanuele
Catania, , Italy
Università degli Studi "G. D'Annunzio"
Chieti Scalo, , Italy
Azienda Ospedaliera "Madonna delle Grazie"
Matera, , Italy
Ospedale San Paolo
Milan, , Italy
Ospedale San Carlo Borromeo
Milan, , Italy
Presidio Ospedaliero San Lorenzo
Palermo, , Italy
Presidio Ospedaliero di Portogruaro
Portogruaro (VE), , Italy
Azienda Policlinico Universitario a Gestione Diret
Udine, , Italy
's-Hertogenbosch, , Netherlands
Maxima Medisch Centrum
Eindhoven, , Netherlands
H. Elvas
Elvas, , Netherlands
Hilversum, , Netherlands
Lieshout, , Netherlands
Waalwijk, , Netherlands
H. Almada
Almada Almada, , Portugal
Hospital Fernando da Fonseca
Amadora Amadora, , Portugal
Hospital de. S. Marta
Lisboa Lisboa, , Portugal
Zentrum Oberdorf
Affoltern am Albis, , Switzerland
Bellinzona, , Switzerland
Gland, , Switzerland
Petit Lancy, , Switzerland
Praxis Dreispitz
Zurich, , Switzerland
The Atherstone Surgery
Atherstone, , United Kingdom
The Medical Centre
Birmingham, , United Kingdom
Waterloo Medical Centre
Blackpool, , United Kingdom
Rowden Surgery
Chippenham, , United Kingdom
The Gables Medical Centre
Coventry, , United Kingdom
Bridge Medical Centre
Crawley, , United Kingdom
Homefield Surgery
Exeter, , United Kingdom
Woodside Health Centre
Glasgow, , United Kingdom
Castle Milk Health Centre
Glasgow, , United Kingdom
Division of Cardiovascular and Endocrine Sciences
Manchester, , United Kingdom
University of Manchester
Manchester, , United Kingdom
Oakside Surgery
Plymouth, , United Kingdom
Norwood Medical Centre
Sheffield, , United Kingdom
Lovemead Group Practice
Trowbridge, , United Kingdom
Countries
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Other Identifiers
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2005-004659-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP-OLM-03-05
Identifier Type: -
Identifier Source: org_study_id