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

Condition(s) targeted: Essential Hypertension

Intervention: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sankyo Pharma Gmbh

Official(s) and/or principal investigator(s):
Anthony Heagerty, MD, Principal Investigator, Affiliation: University of Manchester, Dept. of Medicine

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.

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: To assess the subjects treated to target rate overall and on each treatment combination step.

Secondary outcome:

To assess the influence of several prognostic factors on the need for combination therapy.

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.

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.

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.

To evaluate the safety and tolerability of olmesartan monotherapy and the add-on treatment algorithm after the maximum number of weeks of active treatment.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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participate if their pre-treatment can be withdrawn.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.

Innsbruck 6020, Austria

University Klinik, F. Innere Medizin, Innsbruck 6020, Austria

Diakonissen-Krankenhaus Hospital, Salzburg-Aigen 5026, Austria

Salzburg 5020, Austria

Fulpmes 6166, Austria

Kundl 6250, Austria

Bruxelles 1080, Belgium

Mechelen 2800, Belgium

Allgemeen Ziekenhuis Maria-Middelares, Cardiologie, Campus de Pelikaan, Temse 9140, Belgium

Centre Hospitalier du Bois de l`Abbaye et de Hesba, Department of Intensive Care, Seraing 4100, Belgium

Poussan 34560, France

Strasbourg 67000, France

St Aubin des Châteaux 44110, France

Grenoble 38100, France

St Priest 69800, France

Sorcy Saint Martin 55190, France

Pouilly en Auxois 21320, France

Ancerville 55170, France

Derval 44590, France

St Etienne de Montluc 44360, France

Bourges 18000, France

Yerres 91330, France

Lille 59037, France

Montrevel en Bresse 01340, France

Uniklinik Bonn, Bonn 53111, Germany

Goch 47574, Germany

Weyhe 28844, Germany

Schwenningen 78054, Germany

Haag 83527, Germany

Ev. Krankenhaus Bielefeld, Medizinische Klinik in Bethel - Gilead I, Bielefeld 33617, Germany

VS-Villingen 78050, Germany

Mühldorf / Inn 84453, Germany

Heidelberg 69115, Germany

Heidelberg (Neuenheim) 69120, Germany

Hamburg 20148, Germany

Annweiler 76855, Germany

Bammental 69245, Germany

Balve 58802, Germany

Ospedale San Paolo, Milano 20142, Italy

Azienda Ospedaliera "Madonna delle Grazie", Matera 75100, Italy

Università degli Studi "G. D'Annunzio", Chieti Scalo 66013, Italy

Ospedale Nuovo Cutroni, Barcellona Pozzo di Gotto (ME) 98051, Italy

Azienda Policlinico Universitario a Gestione Diret, Udine 33100, Italy

Ospedale Regina Apostolorum, Albano Laziale (RM) 00041, Italy

Ospedale San Carlo Borromeo, Milano 20153, Italy

Ospedale San Sebastiano, Caserta 81100, Italy

Presidio Ospedaliero di Portogruaro, Portogruaro (VE) 30026, Italy

Ospedale Vittorio Emanuele, Catania 95124, Italy

Presidio Ospedaliero San Lorenzo, Palermo 90146, Italy

Casa di Cura "La Madonnina", Bari 70124, Italy

Ospedale C.G. Mazzoni, Ascoli Piceno 63100, Italy

Lieshout 5737 CB, Netherlands

Maxima Medisch Centrum, Eindhoven 5631 BM, Netherlands

Waalwijk 5144 CB, Netherlands

H. Elvas, Elvas 7350-954, Netherlands

Hilversum 1214 JR, Netherlands

Hertogenbosch 5216 GC, Netherlands

Hospital Fernando da Fonseca, Amadora Amadora 2720-276, Portugal

H. Almada, Almada Almada 2801-951, Portugal

Hospital de. S. Marta, Lisboa Lisboa 1169-024, Portugal

Hospital Clínico Universitario de Santiago, Santiago de Compostela 15706, Spain

Hospital Doce de Octubre, Madrid 28041, Spain

Hospital Residencia Sant Camil, Sant Pere de Ribes 08810, Spain

Hospital Universitario de Puerto Real, Puerta Real Cádiz 11510, Spain

ICSA Instituto de Ciencias de la Salud "Avicena", Zaragoza 50003, Spain

Consulta de Cardiología del Dr. León Martínez de l, Badajoz 06008, Spain

Centro de Salud Murcia Centro, Murcia 30005, Spain

Hospital Clínico Universitario San Cecilio, Granada 18012, Spain

Hospital Marqué de Valdecilla, Santander 39008, Spain

Centro de Salud Vallobín - Concinos, Oviedo 33012, Spain

Centro Hospitalario de Manresa, Manresa 08240, Spain

Hospital Universitario San Juan de Alicante, San Juan de Alicante 03550, Spain

CAP San Andrés - Barcelona, Barcelona 08030, Spain

Hospital Universitario La Paz, Madrid 28046, Spain

Hospital General de L´Hospitalet, Hospitalet de Llobregat 08906, Spain

Praxis Dreispitz, Zurich 8050, Switzerland

Petit-Lancy 1213, Switzerland

Bellinzona 6500, Switzerland

Gland 1196, Switzerland

Zentrum Oberdorf, Affoltern am Albis 8910, Switzerland

Division of Cardiovascular and Endocrine Sciences, Manchester M13 9NT, United Kingdom

Waterloo Medical Centre, Blackpool FY4 3AD, United Kingdom

University of Manchester, Manchester M13 9WL, United Kingdom

Oakside Surgery, Plymouth PL5 3PY, United Kingdom

The Medical Centre, Birmingham B37 7TR, United Kingdom

Lovemead Group Practice, Trowbridge BA14 7EG, United Kingdom

Rowden Surgery, Chippenham SN15 2SB, United Kingdom

Bridge Medical Centre, Crawley RH10 1LL, United Kingdom

Homefield Surgery, Exeter EX1 2QS, United Kingdom

Norwood Medical Centre, Sheffield S5 7HD, United Kingdom

The Atherstone Surgery, Atherstone CV9 1EU, United Kingdom

The Gables Medical Centre, Coventry CV6 4DD, United Kingdom

Woodside Health Centre, Glasgow G20 7LR, United Kingdom

Castle Milk Health Centre, Glasgow G45 9 AW, United Kingdom

Starting date: March 2006
Ending date: April 2008
Last updated: April 28, 2008