Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension (OLMETREAT)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00311155 |
Recruitment Status :
Completed
First Posted : April 5, 2006
Results First Posted : November 10, 2010
Last Update Posted : December 10, 2010
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Essential Hypertension | Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary | Phase 4 |
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 |

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. |
- 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.
- 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.
- 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.
- 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
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311155

Principal Investigator: | Anthony Heagerty, MD | University of Manchester, Dept. of Medicine |
Responsible Party: | Senior Manager - Study Coordination, Daiichi Sankyo Europe, GmbH |
ClinicalTrials.gov Identifier: | NCT00311155 |
Other Study ID Numbers: |
SP-OLM-03-05 2005-004659-36 ( EudraCT Number ) |
First Posted: | April 5, 2006 Key Record Dates |
Results First Posted: | November 10, 2010 |
Last Update Posted: | December 10, 2010 |
Last Verified: | November 2010 |
Olmesartan medoxomil Hypertension |
Hypertension Essential Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Hydrochlorothiazide Olmesartan Olmesartan Medoxomil Antihypertensive Agents Calcium Channel Blockers |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Diuretics Natriuretic Agents Sodium Chloride Symporter Inhibitors Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |