Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2008

Interventions

  • 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

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Change in Mean Trough Sitting Diastolic Blood Pressure
    • Time Frame: 8 weeks
    • Change in mean trough sitting diastolic Blood Pressure 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. Change = Week 16 – Week 8 (baseline).

Secondary Measures

  • Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12
    • Time Frame: 4 weeks
    • Change = Week 12 – Week 8 (baseline).
  • Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.
    • Time Frame: 8 weeks
    • 4 weeks Change = Week 12 – Week 8 (baseline). 8 weeks Change = Week 16 – Week 8 (baseline).
  • Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
    • Time Frame: 8 weeks
    • Change = Week 16 – Week 8 (baseline).
  • Number of Participants Achieving Blood Pressure Goal.
    • Time Frame: 8 weeks

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Daiichi Sankyo
  • Collaborator
    • Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Professor Lars Christian Rump, M.D., Study Chair, University of Ruhr-Bochum

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