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

Tracking Information

First Received Date ^ICMJE

April 3, 2006

Last Updated Date

April 28, 2008

Start Date ^ICMJE

March 2006

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

The rate of subjects treated to target BP overall and on each treatment combination.

Change History

Complete list of historical versions of study NCT00311155 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

To assess the influence of several prognostic factors on the need for combination therapy.
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.
To evaluate the effect of olmesartan montherapy and the add-on treatment algorithm in terms of change of mean sitting sBP and dBP vs. baseline at each visit.
To evaluate the effect of olmesartan montherapy 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.
To evaluate the safety and tolerability of olmesartan monotherapy and the add-on treatment algorithm after the maximun number of weeks of active treatment.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Essential Hypertension

Intervention ^ICMJE

Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

761

Completion Date

April 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00311155

Responsible Party

Senior Manager - Study Coordination, Daiichi Sankyo Europe, GmbH

Study ID Numbers ^ICMJE

SP-OLM-03-05

Study Sponsor ^ICMJE

Sankyo Pharma Gmbh

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Anthony Heagerty, MD

University of Manchester, Dept. of Medicine

Information Provided By

Daiichi Sankyo Inc.

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP