Official Title: “Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide Combination 20/25 mg Versus 40/25 mg in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy”

The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets
  • olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks
• Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg
  • olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ) 40/25 mg + OM/HCTZ 20/25 mg matching placebo
• Experimental: 2
  • olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ)20/25 mg + OM/HCTZ 40/25 matching placebo

Primary Measures

• Change in Mean Trough Sitting Diastolic Blood Pressure
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12
  • Time Frame: 4 weeks
    Safety Issue?: No
• Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.
  • Time Frame: 8 weeks
    Safety Issue?: No
• Change in Daytime, Nighttime and 24-Hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
  • Time Frame: 8 weeks
    Safety Issue?: No
• Number of Participants Achieving Blood Pressure Goal.
  • Time Frame: 8 weeks
    Safety Issue?: No

Inclusion Criteria:

• Male or female Europeans aged 18 years or older with moderate to severe HTN, defined as follows (conventional BP measurements)

Exclusion Criteria:

• Female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period.
• Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases.
• Patients having a history of the following within the last six months:
• myocardial infarction,
• unstable angina pectoris,
• percutaneous coronary intervention,
• severe heart failure,
• hypertensive encephalopathy, cerebrovascular accident (stroke) or
• transient ischaemic attack.
• Patients with clinically significant abnormal laboratory values at screening.
• Patients with secondary HTN.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Daiichi Sankyo Inc.

Overall Clinical Trial Officials and Contacts

Professor Lars Christian Rump, M.D. Study Chair University of Ruhr-Bochum  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00430950

Study ID Number: CS866CM-B-E302

ClinicalTrials.gov Identifier: NCT00430950

Health Authority: EU: EMEA