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Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets
olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Moderate-to-Severe Hypertension, Essential Hypertension, Combination Therapy, Fixed-Combination Dose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ) 40/25 mg + OM/HCTZ 20/25 mg matching placebo

olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ)20/25 mg + OM/HCTZ 40/25 matching placebo

Outcomes

Primary Outcome Measures

Change in Mean Trough Sitting Diastolic Blood Pressure
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 Outcome Measures

Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12
Change = Week 12 - Week 8 (baseline).
Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.
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.
Change = Week 16 - Week 8 (baseline).
Number of Participants Achieving Blood Pressure Goal.

Full Information

First Posted
February 1, 2007
Last Updated
December 20, 2018
Sponsor
Daiichi Sankyo, Inc.
Collaborators
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
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1. Study Identification

Unique Protocol Identification Number
NCT00430950
Brief Title
Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
Collaborators
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Moderate-to-Severe Hypertension, Essential Hypertension, Combination Therapy, Fixed-Combination Dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1011 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ) 40/25 mg + OM/HCTZ 20/25 mg matching placebo
Arm Title
2
Arm Type
Experimental
Arm Description
olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ)20/25 mg + OM/HCTZ 40/25 matching placebo
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets
Intervention Description
olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg
Intervention Description
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks
Primary Outcome Measure Information:
Title
Change in Mean Trough Sitting Diastolic Blood Pressure
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12
Description
Change = Week 12 - Week 8 (baseline).
Time Frame
4 weeks
Title
Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.
Description
4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).
Time Frame
8 weeks
Title
Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
Description
Change = Week 16 - Week 8 (baseline).
Time Frame
8 weeks
Title
Number of Participants Achieving Blood Pressure Goal.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Lars Christian Rump, M.D.
Organizational Affiliation
University of Ruhr-Bochum
Official's Role
Study Chair
Facility Information:
City
Brugge
Country
Belgium
City
Brussels
Country
Belgium
City
Drongen
Country
Belgium
City
Godinne
Country
Belgium
City
Mouscron
Country
Belgium
City
Wetteren
Country
Belgium
City
Berlin
Country
Germany
City
Dortmund
Country
Germany
City
Essen
Country
Germany
City
Frankfurt
Country
Germany
City
Goch
Country
Germany
City
Hamburg
Country
Germany
City
Kallstadt
Country
Germany
City
Karlsruhe
Country
Germany
City
Kassel
Country
Germany
City
Magdeburg
Country
Germany
City
Marburg
Country
Germany
City
Muenchen
Country
Germany
City
Wiesbaden
Country
Germany
City
Wuppertal
Country
Germany
City
Alphen aan den Rijn
Country
Netherlands
City
Amsterdam Zuidoost
Country
Netherlands
City
Andijk
Country
Netherlands
City
De Bilt
Country
Netherlands
City
Den Bosch
Country
Netherlands
City
Den Haag
Country
Netherlands
City
Ewijk
Country
Netherlands
City
Heerlen
Country
Netherlands
City
Hengelo
Country
Netherlands
City
Landgraaf
Country
Netherlands
City
Nijmegen
Country
Netherlands
City
Oud-Beijerland
Country
Netherlands
City
Ridderkerk
Country
Netherlands
City
Wildervank
Country
Netherlands
City
Zwijndrecht
Country
Netherlands
City
Bratislava
Country
Slovakia
City
Levice
Country
Slovakia
City
Lucenec
Country
Slovakia
City
Nitra
Country
Slovakia
City
Nove Zamky
Country
Slovakia
City
Vrable
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
22114906
Citation
Rosenbaum D, Girerd X. Olmesartan medoxomil combined with hydrochlorothiazide improves 24-hour blood pressure control in moderate-to-severe hypertension. Curr Med Res Opin. 2012 Feb;28(2):179-86. doi: 10.1185/03007995.2011.644626. Epub 2012 Jan 9.
Results Reference
derived

Learn more about this trial

Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

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