MedDataX Logo

Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension

NCT ID: NCT00858702

Last Updated: 2017-10-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to test the efficacy and safety of the combination of Calcium Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class) and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not adequately controlled with olmesartan medoxomil alone

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Essential hypertension Combination therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

olmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks

Group Type EXPERIMENTAL

olmesartan medoxomil and a CCB

Intervention Type DRUG

olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks

2

olmesartan medoxomil and a diuretic tablet (of the thiazide class)

Group Type EXPERIMENTAL

olmesartan medoxomil and a diuretic

Intervention Type DRUG

olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

olmesartan medoxomil and a CCB

olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks

Intervention Type DRUG

olmesartan medoxomil and a diuretic

olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Mean seated blood pressure greater than or equal to 140/90 mmHg under circumstances in pre-treatment with olmesartan medoxomil
* Mean 24-hour blood pressure evaluated by ambulatory blood pressure monitoring greater than or equal to 135/80 mmHg under circumstances in pre-treatment with olmesartan medoxomil

Exclusion Criteria

* Patients with secondary hypertension
* Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daiichi Sankyo Co., Ltd.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Research and Development Division

Role: STUDY_DIRECTOR

Daiichi Sankyo Co., Ltd.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tokyo, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OLM004-071

Identifier Type: -

Identifier Source: org_study_id