Olmesartan and an Add-on Treatment in Patients With Mild to Moderate Hypertension - Full Text View

Sponsor:	Sankyo Pharma Gmbh
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00311155

Purpose

This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.

Condition	Intervention	Phase
Essential Hypertension	Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Treat-to-Target Study of Olmesartan Medoxomil and an Add-on Treatment Algorithm Consisting of Hydrochlorothiazide and Amlodipine Besylate in Patients With Mild to Moderate Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

To assess the subjects treated to target rate overall and on each treatment combination step. [ Time Frame: 20 weeks maximun ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the influence of several prognostic factors on the need for combination therapy. [ Time Frame: 20 weeks maximun ] [ Designated as safety issue: No ]
To evaluate the effect of olmesartan monotherapy and the add-on treatment algorithm overall and on each treatment combination step in terms of the percentage of patients achieving certain BP levels. [ Time Frame: 20 weeks maximum ] [ Designated as safety issue: No ]
To evaluate the effect of olmesartan monotherapy and the add-on treatment algorithm in terms of change of mean sitting systolic BP (sBP) and diastolic BP (dBP) versus baseline at each visit. [ Time Frame: 20 weeks maximum ] [ Designated as safety issue: No ]
To evaluate the effect of olmesartan monotherapy and the add-on treatment algorithm in terms of a decrease of greater than or equal to 10 mmHg in mean sitting dBP or a mean sitting dBP of less than 90 mmHg at trough at each visit. [ Time Frame: 20 weeks maximum ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of olmesartan monotherapy and the add-on treatment algorithm after the maximum number of weeks of active treatment. [ Time Frame: 20 weeks maximum ] [ Designated as safety issue: No ]

Enrollment:	761
Study Start Date:	March 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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	Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients age greater than or equal to 18 years with mild to moderate hypertension.
Pre-treated patients with normal or elevated blood pressure are eligible to participate if their pre-treatment can be withdrawn. At the end of the placebo run-in period sitting sBP greater than or equal to 140 and less than 180 mmHg and/or sitting dBP greater than or equal to 90 and less than 110 mmHg at trough.

Exclusion Criteria:

Female patients of childbearing potential must not be pregnant or lactating and must be using adequate contraception.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311155

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Locations

Austria

Innsbruck, Austria, 6020
University Klinik, F. Innere Medizin
Innsbruck, Austria, 6020
Diakonissen-Krankenhaus Hospital
Salzburg-Aigen, Austria, 5026

Salzburg, Austria, 5020

Fulpmes, Austria, 6166

Kundl, Austria, 6250
Belgium

Bruxelles, Belgium, 1080

Mechelen, Belgium, 2800
Allgemeen Ziekenhuis Maria-Middelares, Cardiologie, Campus de Pelikaan
Temse, Belgium, 9140
Centre Hospitalier du Bois de l`Abbaye et de Hesba, Department of Intensive Care
Seraing, Belgium, 4100
France

Poussan, France, 34560

Lille, France, 59037

St Aubin des Châteaux, France, 44110

Grenoble, France, 38100

St Priest, France, 69800

Sorcy Saint Martin, France, 55190

Pouilly en Auxois, France, 21320

Ancerville, France, 55170

Derval, France, 44590

St Etienne de Montluc, France, 44360

Bourges, France, 18000

Yerres, France, 91330

Strasbourg, France, 67000

Montrevel en Bresse, France, 01340
Germany
Uniklinik Bonn
Bonn, Germany, 53111

Goch, Germany, 47574

Weyhe, Germany, 28844

Schwenningen, Germany, 78054

Haag, Germany, 83527

Hamburg, Germany, 20148

VS-Villingen, Germany, 78050

Mühldorf / Inn, Germany, 84453

Heidelberg, Germany, 69115

Heidelberg (Neuenheim), Germany, 69120
Ev. Krankenhaus Bielefeld, Medizinische Klinik in Bethel - Gilead I
Bielefeld, Germany, 33617

Annweiler, Germany, 76855

Bammental, Germany, 69245

Balve, Germany, 58802
Italy
Ospedale San Paolo
Milano, Italy, 20142
Azienda Ospedaliera "Madonna delle Grazie"
Matera, Italy, 75100
Università degli Studi "G. D'Annunzio"
Chieti Scalo, Italy, 66013
Presidio Ospedaliero di Portogruaro
Portogruaro (VE), Italy, 30026
Azienda Policlinico Universitario a Gestione Diret
Udine, Italy, 33100
Ospedale Regina Apostolorum
Albano Laziale (RM), Italy, 00041
Ospedale San Carlo Borromeo
Milano, Italy, 20153
Ospedale San Sebastiano
Caserta, Italy, 81100
Ospedale Nuovo Cutroni
Barcellona Pozzo di Gotto (ME), Italy, 98051
Ospedale Vittorio Emanuele
Catania, Italy, 95124
Presidio Ospedaliero San Lorenzo
Palermo, Italy, 90146
Casa di Cura "La Madonnina"
Bari, Italy, 70124
Ospedale C.G. Mazzoni
Ascoli Piceno, Italy, 63100
Netherlands

Lieshout, Netherlands, 5737 CB
Maxima Medisch Centrum
Eindhoven, Netherlands, 5631 BM

Waalwijk, Netherlands, 5144 CB
H. Elvas
Elvas, Netherlands, 7350-954

Hilversum, Netherlands, 1214 JR

Hertogenbosch, Netherlands, 5216 GC
Portugal
Hospital Fernando da Fonseca
Amadora Amadora, Portugal, 2720-276
H. Almada
Almada Almada, Portugal, 2801-951
Hospital de. S. Marta
Lisboa Lisboa, Portugal, 1169-024
Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Spain, 15706
Hospital Doce de Octubre
Madrid, Spain, 28041
Hospital Residencia Sant Camil
Sant Pere de Ribes, Spain, 08810
Hospital Universitario de Puerto Real
Puerta Real Cádiz, Spain, 11510
ICSA Instituto de Ciencias de la Salud "Avicena"
Zaragoza, Spain, 50003
Centro Hospitalario de Manresa
Manresa, Spain, 08240
Centro de Salud Murcia Centro
Murcia, Spain, 30005
Hospital Clínico Universitario San Cecilio
Granada, Spain, 18012
Hospital Marqué de Valdecilla
Santander, Spain, 39008
Centro de Salud Vallobín - Concinos
Oviedo, Spain, 33012
Consulta de Cardiología del Dr. León Martínez de l
Badajoz, Spain, 06008
Hospital Universitario San Juan de Alicante
San Juan de Alicante, Spain, 03550
CAP San Andrés - Barcelona
Barcelona, Spain, 08030
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital General de L´Hospitalet
Hospitalet de Llobregat, Spain, 08906
Switzerland
Praxis Dreispitz
Zurich, Switzerland, 8050
Zentrum Oberdorf
Affoltern am Albis, Switzerland, 8910

Bellinzona, Switzerland, 6500

Gland, Switzerland, 1196

Petit-Lancy, Switzerland, 1213
United Kingdom
Division of Cardiovascular and Endocrine Sciences
Manchester, United Kingdom, M13 9NT
Waterloo Medical Centre
Blackpool, United Kingdom, FY4 3AD
University of Manchester
Manchester, United Kingdom, M13 9WL
Castle Milk Health Centre
Glasgow, United Kingdom, G45 9 AW
The Medical Centre
Birmingham, United Kingdom, B37 7TR
Lovemead Group Practice
Trowbridge, United Kingdom, BA14 7EG
Rowden Surgery
Chippenham, United Kingdom, SN15 2SB
Bridge Medical Centre
Crawley, United Kingdom, RH10 1LL
Homefield Surgery
Exeter, United Kingdom, EX1 2QS
Norwood Medical Centre
Sheffield, United Kingdom, S5 7HD
The Atherstone Surgery
Atherstone, United Kingdom, CV9 1EU
The Gables Medical Centre
Coventry, United Kingdom, CV6 4DD
Woodside Health Centre
Glasgow, United Kingdom, G20 7LR
Oakside Surgery
Plymouth, United Kingdom, PL5 3PY

Sponsors and Collaborators

Sankyo Pharma Gmbh

Investigators

Principal Investigator:

Anthony Heagerty, MD

University of Manchester, Dept. of Medicine

More Information

No publications provided

Responsible Party:	Daiichi Sankyo Europe, GmbH ( Senior Manager - Study Coordination )
Study ID Numbers:	SP-OLM-03-05
Study First Received:	April 3, 2006
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00311155 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Daiichi Sankyo Inc.:

Olmesartan medoxomil
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Olmesartan medoxomil
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on November 25, 2009