Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension (OLMETREAT)

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

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.

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary

• Study Type: Interventional
• Enrollment (Actual): 694
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Fulpmes, Austria, 6166
  • Innsbruck, Austria, 6020
  • Innsbruck, Austria, 6020
    • University Klinik, F. Innere Medizin
  • Kundl, Austria, 6250
  • Salzburg, Austria, 5020
  • Salzburg-Aigen, Austria, 5026
    • Diakonissen-Krankenhaus Hospital
• Belgium
  • Bruxelles, Belgium, 1080
  • Mechelen, Belgium, 2800
  • Seraing, Belgium, 4100
    • Centre Hospitalier du Bois de l'Abbaye et de Hesba, Department of Intensive Care
  • Temse, Belgium, 9140
    • Allgemeen Ziekenhuis Maria-Middelares, Cardiologie, Campus de Pelikaan
• France
  • Ancerville, France, 55170
  • Bourges, France, 18000
  • Derval, France, 44590
  • Grenoble, France, 38100
  • Lille, France, 59037
  • Montrevel en Bresse, France, 01340
  • Pouilly en Auxois, France, 21320
  • Poussan, France, 34560
  • Sorcy Saint Martin, France, 55190
  • St Aubin des Châteaux, France, 44110
  • St Etienne de Montluc, France, 44360
  • St Priest, France, 69800
  • Strasbourg, France, 67000
  • Yerres, France, 91330
• Germany
  • Annweiler, Germany, 76855
  • Balve, Germany, 58802
  • Bammental, Germany, 69245
  • Bielefeld, Germany, 33617
    • Ev. Krankenhaus Bielefeld, Medizinische Klinik in Bethel - Gilead I
  • Bonn, Germany, 53111
    • Uniklinik Bonn
  • Goch, Germany, 47574
  • Haag, Germany, 83527
  • Hamburg, Germany, 20148
  • Heidelberg, Germany, 69115
  • Heidelberg (Neuenheim), Germany, 69120
  • Mühldorf / Inn, Germany, 84453
  • Schwenningen, Germany, 78054
  • VS-Villingen, Germany, 78050
  • Weyhe, Germany, 28844
• Italy
  • Albano Laziale (RM), Italy, 00041
    • Ospedale Regina Apostolorum
  • Ascoli Piceno, Italy, 63100
    • Ospedale C.G. Mazzoni
  • Barcellona Pozzo di Gotto (ME), Italy, 98051
    • Ospedale Nuovo Cutroni
  • Bari, Italy, 70124
    • Casa di Cura "La Madonnina"
  • Caserta, Italy, 81100
    • Ospedale San Sebastiano
  • Catania, Italy, 95124
    • Ospedale Vittorio Emanuele
  • Chieti Scalo, Italy, 66013
    • Università degli Studi "G. D'Annunzio"
  • Matera, Italy, 75100
    • Azienda Ospedaliera "Madonna delle Grazie"
  • Milano, Italy, 20142
    • Ospedale San Paolo
  • Milano, Italy, 20153
    • Ospedale San Carlo Borromeo
  • Palermo, Italy, 90146
    • Presidio Ospedaliero San Lorenzo
  • Portogruaro (VE), Italy, 30026
    • Presidio Ospedaliero di Portogruaro
  • Udine, Italy, 33100
    • Azienda Policlinico Universitario a Gestione Diret
• Netherlands
  • Eindhoven, Netherlands, 5631 BM
    • Maxima Medisch Centrum
  • Elvas, Netherlands, 7350-954
    • H. Elvas
  • Hertogenbosch, Netherlands, 5216 GC
  • Hilversum, Netherlands, 1214 JR
  • Lieshout, Netherlands, 5737 CB
  • Waalwijk, Netherlands, 5144 CB
• Portugal
  • Almada Almada, Portugal, 2801-951
    • H. Almada
  • Amadora Amadora, Portugal, 2720-276
    • Hospital Fernando da Fonseca
  • Lisboa Lisboa, Portugal, 1169-024
    • Hospital de. S. Marta
• Switzerland
  • Affoltern am Albis, Switzerland, 8910
    • Zentrum Oberdorf
  • Bellinzona, Switzerland, 6500
  • Gland, Switzerland, 1196
  • Petit-Lancy, Switzerland, 1213
  • Zurich, Switzerland, 8050
    • Praxis Dreispitz
• United Kingdom
  • Atherstone, United Kingdom, CV9 1EU
    • The Atherstone Surgery
  • Birmingham, United Kingdom, B37 7TR
    • The Medical Centre
  • Blackpool, United Kingdom, FY4 3AD
    • Waterloo Medical Centre
  • Chippenham, United Kingdom, SN15 2SB
    • Rowden Surgery
  • Coventry, United Kingdom, CV6 4DD
    • The Gables Medical Centre
  • Crawley, United Kingdom, RH10 1LL
    • Bridge Medical Centre
  • Exeter, United Kingdom, EX1 2QS
    • Homefield Surgery
  • Glasgow, United Kingdom, G20 7LR
    • Woodside Health Centre
  • Glasgow, United Kingdom, G45 9 AW
    • Castle Milk Health Centre
  • Manchester, United Kingdom, M13 9WL
    • University of Manchester
  • Manchester, United Kingdom, M13 9NT
    • Division of Cardiovascular and Endocrine Sciences
  • Plymouth, United Kingdom, PL5 3PY
    • Oakside Surgery
  • Sheffield, United Kingdom, S5 7HD
    • Norwood Medical Centre
  • Trowbridge, United Kingdom, BA14 7EG
    • Lovemead Group Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline to ≤20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline to ≤20 weeks
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.	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.	Baseline to ≤20 weeks
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	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	Baseline to ≤20 weeks
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

Collaborators and Investigators

• Sponsor: Sankyo Pharma Gmbh
• Investigators: Principal Investigator: Anthony Heagerty, MD, University of Manchester, Dept. of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: April 3, 2006
• First Submitted That Met QC Criteria: April 3, 2006
• First Posted (Estimate): April 5, 2006

Study Record Updates

• Last Update Posted (Estimate): December 10, 2010
• Last Update Submitted That Met QC Criteria: November 23, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Hypertension; Olmesartan medoxomil
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Amlodipine; Olmesartan; Olmesartan Medoxomil; Hydrochlorothiazide
• Other Study ID Numbers: SP-OLM-03-05; 2005-004659-36 (EudraCT Number)