Clinical trial NCT00311155: Olmesartan and an add-on Treatment 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Hypertension
Keywords: Olmesartan medoxomil
Hypertension
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2006-04-05
Enrollment: 694
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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with normal or elevated blood pressure (BP) are eligible to participate if their pre-treatment medication can be withdrawn.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:

* 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.

Primary outcomes:
measure: The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.
timeFrame: Baseline to ≤20 weeks
Secondary outcomes:
measure: Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved
timeFrame: Baseline to ≤20 weeks
measure: Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.
timeFrame: Baseline to ≤20 weeks
measure: Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved
timeFrame: Baseline to ≤20 weeks
measure: Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
timeFrame: Baseline to ≤20 weeks
measure: Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
timeFrame: Baseline to ≤20 weeks
Other outcomes:
Locations:
city: Fulpmes
country: Austria
city: Innsbruck
country: Austria
facility: University Klinik, F. Innere Medizin
city: Innsbruck
country: Austria
city: Kundl
country: Austria
city: Salzburg-Aigen
country: Austria
facility: Diakonissen-Krankenhaus Hospital
city: Salzburg
country: Austria
city: Bruxelles
country: Belgium
city: Mechelen
country: Belgium
city: Seraing
country: Belgium
facility: Centre Hospitalier du Bois de l'Abbaye et de Hesba, Department of Intensive Care
city: Temse
country: Belgium
facility: Allgemeen Ziekenhuis Maria-Middelares, Cardiologie, Campus de Pelikaan
city: Ancerville
country: France
city: Bourges
country: France
city: Derval
country: France
city: Grenoble
country: France
city: Lille
country: France
city: Montrevel en Bresse
country: France
city: Pouilly en Auxois
country: France
city: Poussan
country: France
city: Sorcy Saint Martin
country: France
city: St Aubin des Châteaux
country: France
city: St Etienne de Montluc
country: France
city: St Priest
country: France
city: Strasbourg
country: France
city: Yerres
country: France
city: Annweiler
country: Germany
city: Balve
country: Germany
city: Bammental
country: Germany
city: Bielefeld
country: Germany
facility: Ev. Krankenhaus Bielefeld, Medizinische Klinik in Bethel - Gilead I
city: Bonn
country: Germany
facility: Uniklinik Bonn
city: Goch
country: Germany
city: Haag
country: Germany
city: Hamburg
country: Germany
city: Heidelberg (Neuenheim)
country: Germany
city: Heidelberg
country: Germany
city: Mühldorf / Inn
country: Germany
city: Schwenningen
country: Germany
city: VS-Villingen
country: Germany
city: Weyhe
country: Germany
city: Albano Laziale (RM)
country: Italy
facility: Ospedale Regina Apostolorum
city: Ascoli Piceno
country: Italy
facility: Ospedale C.G. Mazzoni
city: Barcellona Pozzo di Gotto (ME)
country: Italy
facility: Ospedale Nuovo Cutroni
city: Bari
country: Italy
facility: Casa di Cura "La Madonnina"
city: Caserta
country: Italy
facility: Ospedale San Sebastiano
city: Catania
country: Italy
facility: Ospedale Vittorio Emanuele
city: Chieti Scalo
country: Italy
facility: Università degli Studi "G. D'Annunzio"
city: Matera
country: Italy
facility: Azienda Ospedaliera "Madonna delle Grazie"
city: Milano
country: Italy
facility: Ospedale San Paolo
city: Milano
country: Italy
facility: Ospedale San Carlo Borromeo
city: Palermo
country: Italy
facility: Presidio Ospedaliero San Lorenzo
city: Portogruaro (VE)
country: Italy
facility: Presidio Ospedaliero di Portogruaro
city: Udine
country: Italy
facility: Azienda Policlinico Universitario a Gestione Diret
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Elvas
country: Netherlands
facility: H. Elvas
city: Hertogenbosch
country: Netherlands
city: Hilversum
country: Netherlands
city: Lieshout
country: Netherlands
city: Waalwijk
country: Netherlands
city: Almada Almada
country: Portugal
facility: H. Almada
city: Amadora Amadora
country: Portugal
facility: Hospital Fernando da Fonseca
city: Lisboa Lisboa
country: Portugal
facility: Hospital de. S. Marta
city: Affoltern am Albis
country: Switzerland
facility: Zentrum Oberdorf
city: Bellinzona
country: Switzerland
city: Gland
country: Switzerland
city: Petit-Lancy
country: Switzerland
city: Zurich
country: Switzerland
facility: Praxis Dreispitz
city: Atherstone
country: United Kingdom
facility: The Atherstone Surgery
city: Birmingham
country: United Kingdom
facility: The Medical Centre
city: Blackpool
country: United Kingdom
facility: Waterloo Medical Centre
city: Chippenham
country: United Kingdom
facility: Rowden Surgery
city: Coventry
country: United Kingdom
facility: The Gables Medical Centre
city: Crawley
country: United Kingdom
facility: Bridge Medical Centre
city: Exeter
country: United Kingdom
facility: Homefield Surgery
city: Glasgow
country: United Kingdom
facility: Woodside Health Centre
city: Glasgow
country: United Kingdom
facility: Castle Milk Health Centre
city: Manchester
country: United Kingdom
facility: Division of Cardiovascular and Endocrine Sciences
city: Manchester
country: United Kingdom
facility: University of Manchester
city: Plymouth
country: United Kingdom
facility: Oakside Surgery
city: Sheffield
country: United Kingdom
facility: Norwood Medical Centre
city: Trowbridge
country: United Kingdom
facility: Lovemead Group Practice
Study officials:
affiliation: University of Manchester, Dept. of Medicine
name: Anthony Heagerty, MD
role: PRINCIPAL_INVESTIGATOR
References: