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Use of the 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 and placebo
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets
olmesartan medoxomil/hydrochlorothiazide tablets
olmesartan medoxomil/hydrochlorothiazide tablets
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 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

4

1

3

2

Arm Description

olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Outcomes

Primary Outcome Measures

Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16
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 Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.
Change = Week 16 - Week 8 (baseline).
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.
Change = Week 12 - Week 8 (baseline).
Number of Patients Achieving Target Blood Pressure at Week 16
Target Blood Pressure is diastolic blood pressure (dBP) < 90 mmHg and systolic blood pressure (sBP) < 140 mmHg for non-diabetics, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics
Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
Change = Week 16 - Week 8 (baseline).
Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
Change = Week 16 - Week 8 (baseline).
Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
Change = Week 16 - Week 8 (baseline).

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
NCT00430508
Brief Title
Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Sankyo, Inc.
Collaborators
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

4. Oversight

Data Monitoring Committee
No

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
972 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4
Arm Type
Experimental
Arm Description
olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Arm Title
1
Arm Type
Experimental
Arm Description
olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Arm Title
3
Arm Type
Experimental
Arm Description
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
Arm Title
2
Arm Type
Experimental
Arm Description
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo
Intervention Description
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets
Intervention Description
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil/hydrochlorothiazide tablets
Intervention Description
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil/hydrochlorothiazide tablets
Intervention Description
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
Primary Outcome Measure Information:
Title
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16
Description
Change = Week 16 - Week 8 (baseline).
Time Frame
8 weeks, change = week 16 - week 8
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, change = week 12 - week 8
Title
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.
Description
Change = Week 16 - Week 8 (baseline).
Time Frame
8 weeks, change = week 16 - week 8
Title
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.
Description
Change = Week 12 - Week 8 (baseline).
Time Frame
4 weeks, change = week 12 - week 8
Title
Number of Patients Achieving Target Blood Pressure at Week 16
Description
Target Blood Pressure is diastolic blood pressure (dBP) < 90 mmHg and systolic blood pressure (sBP) < 140 mmHg for non-diabetics, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics
Time Frame
8 weeks
Title
Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
Description
Change = Week 16 - Week 8 (baseline).
Time Frame
8 weeks, change = week 16 - week 8
Title
Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
Description
Change = Week 16 - Week 8 (baseline).
Time Frame
8 weeks, change = week 16 - week 8
Title
Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
Description
Change = Week 16 - Week 8 (baseline).
Time Frame
8 weeks, change = week 16 - week 8

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 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.
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
Pleven
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Beroun
Country
Czechia
City
Brno
Country
Czechia
City
Chrudim
Country
Czechia
City
Hradec Kralove
Country
Czechia
City
Jindrichuv Hradec
Country
Czechia
City
Kutna Hora
Country
Czechia
City
Ostrava
Country
Czechia
City
Pardubice
Country
Czechia
City
Plzen
Country
Czechia
City
Prague
Country
Czechia
City
Pribram
Country
Czechia
City
Revnice
Country
Czechia
City
Sokolov
Country
Czechia
City
Trutnov
Country
Czechia
City
Langres
Country
France
City
Paris
Country
France
City
Pessac
Country
France
City
Berlin
Country
Germany
City
Bochum
Country
Germany
City
Dietzenbach
Country
Germany
City
Franfurt
Country
Germany
City
Friedberg
Country
Germany
City
Ingelheim
Country
Germany
City
Karlsbad
Country
Germany
City
Leipzig
Country
Germany
City
Offenbach
Country
Germany
City
Siegen
Country
Germany
City
Stuhr-Brinkum
Country
Germany
City
Elblag
Country
Poland
City
Gdansk
Country
Poland
City
Inowroclaw
Country
Poland
City
Katowice
Country
Poland
City
Krakow
Country
Poland
City
Linia
Country
Poland
City
Lodz
Country
Poland
City
Olawa
Country
Poland
City
Poznan
Country
Poland
City
Warszawa
Country
Poland
City
Wroclaw
Country
Poland
City
Zamosc
Country
Poland
City
Girona
Country
Spain
City
Granada
Country
Spain
City
Madrid
Country
Spain
City
Oviedo
Country
Spain
City
Dnepropetrovsk
Country
Ukraine
City
Donetsk
Country
Ukraine
City
Kharkiv
Country
Ukraine
City
Kiev
Country
Ukraine
City
Lviv
Country
Ukraine
City
Odessa
Country
Ukraine
City
Uzhgorod
Country
Ukraine
City
Vinnytsia
Country
Ukraine
City
Zaporizhzhya
Country
Ukraine

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

Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

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