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: June 2008

Intervention(s) in this Clinical Trial

• Drug: olmesartan medoxomil
  • olmesartan medoxomil 40 mg tablets once a day for 8 weeks
• Drug: olmesartan medoxomil + hydrochlorothiazide
  • olmesartan medoxomil/hydrochlorothiazide 20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks
• Drug: olmesartan medoxomil + hydrochlorothiazide tablets
  • olmesartan medoxomil + hydrochlorothiazide tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks
• Other: olmesarsan medoxomil
  • Taper off of hypertension medication except for untreated patients or those already on olmesartan medoxomil

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Taper off current medication - up to 5 weeks
• Active Comparator: 2
  • Olmesartan medoxomil, 40mg tablets once a day for 8 weeks
• Experimental: 3
  • olmesartan medoxomil/hydrochlorothiazide 20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks
• Experimental: 4
  • olmesartan medoxomil + hydrochlorothiazide tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks

Primary Measures

• To compare the efficacy in lowering mean trough sitting dBP between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline.
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Reduction in sitting systolic blood pressure.
  • Time Frame: 8 weeks
    Safety Issue?: No
• Reduction in daytime, nighttime and 24-hr blood pressure evaluated by ABPM.
  • Time Frame: 8 weeks
    Safety Issue?: No
• Percentage of patients achieving BP goal.
  • Time Frame: 8 weeks
    Safety Issue?: No
• Safety and tolerability.
  • 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  

Overall Contact: Dr. Lars Christian Rump, MD; PhD 0049 2323 499 1670 Christian.Rump@ruhr-uni-bochum.de

Information obtained from ClinicalTrials.gov on September 05, 2008

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