Olmesartan and an Add-on Treatment in Patients With Mild to Moderate Hypertension - Full Text View

Sponsored by:	Sankyo Pharma Gmbh
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00311155

Purpose

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	Intervention	Phase
Essential Hypertension	Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary	Phase IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

To assess the subjects treated to target rate overall and on each treatment combination step. [ Time Frame: 20 weeks maximun ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the influence of several prognostic factors on the need for combination therapy. [ Time Frame: 20 weeks maximun ] [ Designated as safety issue: No ]
To evaluate the effect of olmesartan monotherapy and the add-on treatment algorithm overall and on each treatment combination step in terms of the percentage of patients achieving certain BP levels. [ Time Frame: 20 weeks maximum ] [ Designated as safety issue: No ]
To evaluate the effect of olmesartan monotherapy and the add-on treatment algorithm in terms of change of mean sitting systolic BP (sBP) and diastolic BP (dBP) versus baseline at each visit. [ Time Frame: 20 weeks maximum ] [ Designated as safety issue: No ]
To evaluate the effect of olmesartan monotherapy and the add-on treatment algorithm in terms of a decrease of greater than or equal to 10 mmHg in mean sitting dBP or a mean sitting dBP of less than 90 mmHg at trough at each visit. [ Time Frame: 20 weeks maximum ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of olmesartan monotherapy and the add-on treatment algorithm after the maximum number of weeks of active treatment. [ Time Frame: 20 weeks maximum ] [ Designated as safety issue: No ]

Enrollment:	761
Study Start Date:	March 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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 are eligible to participate if their pre-treatment can be withdrawn. At the end of the placebo run-in period sitting sBP greater than or equal to 140 and less than 180 mmHg and/or sitting dBP 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311155

Show 94 Study Locations

Sponsors and Collaborators

Sankyo Pharma Gmbh

Investigators

Principal Investigator:

Anthony Heagerty, MD

University of Manchester, Dept. of Medicine

More Information

No publications provided

Responsible Party:	Daiichi Sankyo Europe, GmbH ( Senior Manager - Study Coordination )
Study ID Numbers:	SP-OLM-03-05
Study First Received:	April 3, 2006
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00311155 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Daiichi Sankyo Inc.:

Olmesartan medoxomil
Hypertension

Study placed in the following topic categories:

Essential Hypertension
Vasodilator Agents
Diuretics
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Olmesartan medoxomil
Cardiovascular Agents

Angiotensin II
Antihypertensive Agents
Hydrochlorothiazide
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Calcium, Dietary
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Olmesartan medoxomil
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009