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

Essential Hypertension Clinical Trial

— OLMETREAT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311155
• Other study ID #: SP-OLM-03-05
• Secondary ID: 2005-004659-36
• Status: Completed
• Phase: Phase 4
• First received: April 3, 2006
• Last updated: November 23, 2010
• Start date: March 2006
• Est. completion date: April 2008

Study information

• Verified date: November 2010
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 694
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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with normal or elevated blood pressure (BP) are eligible to participate if their pre-treatment medication can be withdrawn.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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Austria	University Klinik, F. Innere Medizin	Innsbruck
Austria	Diakonissen-Krankenhaus Hospital	Salzburg-Aigen
Belgium	Centre Hospitalier du Bois de l`Abbaye et de Hesba, Department of Intensive Care	Seraing
Belgium	Allgemeen Ziekenhuis Maria-Middelares, Cardiologie, Campus de Pelikaan	Temse
Germany	Ev. Krankenhaus Bielefeld, Medizinische Klinik in Bethel - Gilead I	Bielefeld
Germany	Uniklinik Bonn	Bonn
Italy	Ospedale Regina Apostolorum	Albano Laziale (RM)
Italy	Ospedale C.G. Mazzoni	Ascoli Piceno
Italy	Ospedale Nuovo Cutroni	Barcellona Pozzo di Gotto (ME)
Italy	Casa di Cura "La Madonnina"	Bari
Italy	Ospedale San Sebastiano	Caserta
Italy	Ospedale Vittorio Emanuele	Catania
Italy	Università degli Studi "G. D'Annunzio"	Chieti Scalo
Italy	Azienda Ospedaliera "Madonna delle Grazie"	Matera
Italy	Ospedale San Carlo Borromeo	Milano
Italy	Ospedale San Paolo	Milano
Italy	Presidio Ospedaliero San Lorenzo	Palermo
Italy	Presidio Ospedaliero di Portogruaro	Portogruaro (VE)
Italy	Azienda Policlinico Universitario a Gestione Diret	Udine
Netherlands	Maxima Medisch Centrum	Eindhoven
Netherlands	H. Elvas	Elvas
Portugal	H. Almada	Almada Almada
Portugal	Hospital Fernando da Fonseca	Amadora Amadora
Portugal	Hospital de. S. Marta	Lisboa Lisboa
Switzerland	Zentrum Oberdorf	Affoltern am Albis
Switzerland	Praxis Dreispitz	Zurich
United Kingdom	The Atherstone Surgery	Atherstone
United Kingdom	The Medical Centre	Birmingham
United Kingdom	Waterloo Medical Centre	Blackpool
United Kingdom	Rowden Surgery	Chippenham
United Kingdom	The Gables Medical Centre	Coventry
United Kingdom	Bridge Medical Centre	Crawley
United Kingdom	Homefield Surgery	Exeter
United Kingdom	Castle Milk Health Centre	Glasgow
United Kingdom	Woodside Health Centre	Glasgow
United Kingdom	Division of Cardiovascular and Endocrine Sciences	Manchester
United Kingdom	University of Manchester	Manchester
United Kingdom	Oakside Surgery	Plymouth
United Kingdom	Norwood Medical Centre	Sheffield
United Kingdom	Lovemead Group Practice	Trowbridge

Sponsors (1)

Lead Sponsor	Collaborator
Sankyo Pharma Gmbh

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Italy,  Netherlands,  Portugal,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment		Baseline to =20 weeks	No
Secondary	Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment		Baseline to =20 weeks	No