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

November 23, 2010 updated by: Sankyo Pharma Gmbh

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
694

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 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.
Baseline to ≤20 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 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.
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.
Time Frame: 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.
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
Time Frame: 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
Baseline to ≤20 weeks
Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
Time Frame: Baseline to ≤20 weeks
Baseline to ≤20 weeks
Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
Time Frame: Baseline to ≤20 weeks
Baseline to ≤20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sankyo Pharma Gmbh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anthony Heagerty, MD, University of Manchester, Dept. of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SP-OLM-03-05
  • 2005-004659-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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