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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Essential Hypertension	Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	694 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	March 2006
Actual Primary Completion Date :	April 2008
Actual Study Completion Date :	April 2008

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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
4. 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 ]
5. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 79 Study Locations

Sponsors and Collaborators

Sankyo Pharma Gmbh

Investigators

Principal Investigator:	Anthony Heagerty, MD	University of Manchester, Dept. of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Senior Manager - Study Coordination, Daiichi Sankyo Europe, GmbH
ClinicalTrials.gov Identifier:	NCT00311155 History of Changes
Other Study ID Numbers:	SP-OLM-03-05; 2005-004659-36 ( EudraCT Number )
First Posted:	April 5, 2006
Results First Posted:	November 10, 2010
Last Update Posted:	December 10, 2010
Last Verified:	November 2010

Keywords provided by Daiichi Sankyo, Inc.:

Olmesartan medoxomil; Hypertension

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Olmesartan; Amlodipine; Hydrochlorothiazide; Olmesartan Medoxomil; Antihypertensive Agents; Calcium Channel Blockers	Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Sodium Chloride Symporter Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists