Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension
- Conditions
- Essential Hypertension
- Interventions
- Registration Number
- NCT00311155
- Lead Sponsor
- Sankyo Pharma Gmbh
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 694
- 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with normal or elevated blood pressure (BP) are eligible to participate if their pre-treatment medication can be withdrawn.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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 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
- Primary Outcome Measures
Name Time Method 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. Baseline to ≤20 weeks For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - \<130 mm Hg; Diastolic - \<80 mm Hg.
- Secondary Outcome Measures
Name Time Method 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 Baseline to ≤20 weeks Normalized blood pressure is defined as a mean sitting systolic blood (sBP) pressure at trough of \<140 mmHg and mean sitting diastolic blood pressure (dBP)of \<90 mmHg for non-diabetic patients or a mean sitting sBP at trough of \<130 mmHg and mean sitting dBP \<80 mmHg for diabetic patients.
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. Baseline to ≤20 weeks Diastolic responders were defined as a participant who is a normaliser or has a lowering of the mean sitting diastolic blood pressure of ≥10 mmHg at trough.
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 Baseline to ≤20 weeks Systolic responders defined as a participant who is a normaliser or has a lowering of the mean sitting systolic blood pressure of ≥20 mmHg at trough
Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment Baseline to ≤20 weeks Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment Baseline to ≤20 weeks
Trial Locations
- Locations (40)
Ospedale San Paolo
🇮🇹Milano, Italy
Hospital Fernando da Fonseca
🇵🇹Amadora Amadora, Portugal
Centre Hospitalier du Bois de l'Abbaye et de Hesba, Department of Intensive Care
🇧🇪Seraing, Belgium
University Klinik, F. Innere Medizin
🇦🇹Innsbruck, Austria
Diakonissen-Krankenhaus Hospital
🇦🇹Salzburg-Aigen, Austria
Allgemeen Ziekenhuis Maria-Middelares, Cardiologie, Campus de Pelikaan
🇧🇪Temse, Belgium
Ev. Krankenhaus Bielefeld, Medizinische Klinik in Bethel - Gilead I
🇩🇪Bielefeld, Germany
Ospedale Regina Apostolorum
🇮🇹Albano Laziale (RM), Italy
Uniklinik Bonn
🇩🇪Bonn, Germany
Ospedale C.G. Mazzoni
🇮🇹Ascoli Piceno, Italy
Ospedale San Sebastiano
🇮🇹Caserta, Italy
Ospedale Nuovo Cutroni
🇮🇹Barcellona Pozzo di Gotto (ME), Italy
Ospedale Vittorio Emanuele
🇮🇹Catania, Italy
Casa di Cura "La Madonnina"
🇮🇹Bari, Italy
Università degli Studi "G. D'Annunzio"
🇮🇹Chieti Scalo, Italy
Presidio Ospedaliero San Lorenzo
🇮🇹Palermo, Italy
Azienda Ospedaliera "Madonna delle Grazie"
🇮🇹Matera, Italy
Maxima Medisch Centrum
🇳🇱Eindhoven, Netherlands
Ospedale San Carlo Borromeo
🇮🇹Milano, Italy
Presidio Ospedaliero di Portogruaro
🇮🇹Portogruaro (VE), Italy
Azienda Policlinico Universitario a Gestione Diret
🇮🇹Udine, Italy
H. Elvas
🇳🇱Elvas, Netherlands
H. Almada
🇵🇹Almada Almada, Portugal
Hospital de. S. Marta
🇵🇹Lisboa Lisboa, Portugal
Zentrum Oberdorf
🇨🇭Affoltern am Albis, Switzerland
The Atherstone Surgery
🇬🇧Atherstone, United Kingdom
Praxis Dreispitz
🇨🇭Zurich, Switzerland
The Medical Centre
🇬🇧Birmingham, United Kingdom
Rowden Surgery
🇬🇧Chippenham, United Kingdom
Waterloo Medical Centre
🇬🇧Blackpool, United Kingdom
Bridge Medical Centre
🇬🇧Crawley, United Kingdom
Homefield Surgery
🇬🇧Exeter, United Kingdom
The Gables Medical Centre
🇬🇧Coventry, United Kingdom
Woodside Health Centre
🇬🇧Glasgow, United Kingdom
University of Manchester
🇬🇧Manchester, United Kingdom
Castle Milk Health Centre
🇬🇧Glasgow, United Kingdom
Division of Cardiovascular and Endocrine Sciences
🇬🇧Manchester, United Kingdom
Oakside Surgery
🇬🇧Plymouth, United Kingdom
Norwood Medical Centre
🇬🇧Sheffield, United Kingdom
Lovemead Group Practice
🇬🇧Trowbridge, United Kingdom