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Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00430508
First Posted: February 2, 2007
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Daiichi Sankyo Europe, GmbH
Information provided by:
Daiichi Sankyo, Inc.
  Purpose
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.

Condition Intervention Phase
Essential Hypertension Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets Drug: olmesartan medoxomil/hydrochlorothiazide tablets Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Hydrochlorothiazide (HCTZ) Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil (OM) 40 mg Monotherapy

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:
  • Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16 [ Time Frame: 8 weeks, change = week 16 - week 8 ]

Secondary Outcome 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 ]
  • Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16. [ Time Frame: 8 weeks, change = week 16 - week 8 ]
  • Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12. [ Time Frame: 4 weeks, change = week 12 - week 8 ]
  • Number of Patients Achieving Target Blood Pressure at Week 16 [ Time Frame: 8 weeks ]
  • Change in Mean 24-Hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. [ Time Frame: 8 weeks, change = week 16 - week 8 ]
  • Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. [ Time Frame: 8 weeks, change = week 16 - week 8 ]
  • Change in Mean Night-Time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. [ Time Frame: 8 weeks, change = week 16 - week 8 ]

Enrollment: 972
Study Start Date: February 2007
Study Completion Date: May 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4
olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week
Experimental: 1
olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Drug: olmesartan medoxomil/hydrochlorothiazide tablets
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Experimental: 3
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
Drug: olmesartan medoxomil/hydrochlorothiazide tablets
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
Experimental: 2
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female Europeans aged 18 years or older with moderate to severe hypertension (HTN)

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430508


  Show 55 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Daiichi Sankyo Europe, GmbH
Investigators
Study Chair: Professor Lars Christian Rump, M.D. University of Ruhr-Bochum
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bettina Ammentorp, Daichi Sankyo Europe, GmbH
ClinicalTrials.gov Identifier: NCT00430508     History of Changes
Other Study ID Numbers: CS866CM-B-E301
First Submitted: February 1, 2007
First Posted: February 2, 2007
Results First Submitted: February 9, 2009
Results First Posted: June 17, 2009
Last Update Posted: July 29, 2009
Last Verified: June 2009

Keywords provided by Daiichi Sankyo, Inc.:
Moderate-to-Severe Hypertension
Essential Hypertension
Combination Therapy
Fixed-Combination Dose

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Hydrochlorothiazide
Olmesartan Medoxomil
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists