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Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Europe, GmbH
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00430508
First received: February 1, 2007
Last updated: June 17, 2009
Last verified: June 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16. [ Time Frame: 8 weeks, change = week 16 - week 8 ] [ Designated as safety issue: No ]
  • Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12. [ Time Frame: 4 weeks, change = week 12 - week 8 ] [ Designated as safety issue: No ]
  • Number of Patients Achieving Target Blood Pressure at Week 16 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Daiichi Sankyo Inc.

Additional 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
Study First Received: February 1, 2007
Results First Received: February 9, 2009
Last Updated: June 17, 2009
Health Authority: EU: EMEA
Germany: Bundesministerium fur
Spain: Ministry of Health
Italy: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Bulgaria: Bulgarian Drug Agency
Ukraine: Ministry of Health
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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
Hydrochlorothiazide
Olmesartan medoxomil
Olmesartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 16, 2013