Essential HypertensionPhase 3NCT00430508

Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

A Phase 3 study testing olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and olmesartan medoxomil/hydrochlorothiazide tablets in people with Essential Hypertension, run by Daiichi Sankyo at 55 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Essential Hypertension
What is being tested?: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and olmesartan medoxomil/hydrochlorothiazide tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 972 participants
Where: 55 sitesin 7 countries
Study dates: Feb 2007to May 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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,

Show all 12Show fewer

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.

Trial locations and contacts

55 sites in 7 countries.

Country

City, postcode or hospital

55 sites in 7 countries

Czechia14 sites

Study site
Beroun
Study site
Brno
Study site
Chrudim
Study site
Hradec Králové
Study site
Jindřichův Hradec
Study site
Kutná Hora
Study site
Ostrava
Study site
Pardubice
Study site
Pilsen
Study site
Prague
Study site
Příbram
Study site
Řevnice
Study site
Sokolov
Study site
Trutnov

Other trials in Czechia

Poland12 sites

Study site
Elblag
Study site
Gdansk
Study site
Inowrocław
Study site
Katowice
Study site
Krakow
Study site
Linia
Study site
Lodz
Study site
Oława
Study site
Poznan
Study site
Warsaw
Study site
Wroclaw
Study site
Zamość

Other trials in Poland

Germany11 sites

Study site
Berlin
Study site
Bochum
Study site
Dietzenbach
Study site
Franfurt
Study site
Friedberg
Study site
Ingelheim
Study site
Karlsbad
Study site
Leipzig
Study site
Offenbach
Study site
Siegen
Study site
Stuhr-Brinkum

Other trials in Germany

Ukraine9 sites

Study site
Dnipro
Study site
Donetsk
Study site
Kharkiv
Study site
Kiev
Study site
Lviv
Study site
Odesa
Study site
Uzhhorod
Study site
Vinnytsia
Study site
Zaporizhzhya

Other trials in Ukraine

Spain4 sites

Study site
Girona
Study site
Granada
Study site
Madrid
Study site
Oviedo

Other trials in Spain

France3 sites

Study site
Langres
Study site
Paris
Study site
Pessac

Other trials in France

Bulgaria2 sites

Study site
Pleven
Study site
Sofia

Other trials in Bulgaria

About this study

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

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.

Conditions: Essential Hypertension
Being tested: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo, olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets, olmesartan medoxomil/hydrochlorothiazide tablets
Keywords: Moderate-to-Severe Hypertension, Essential Hypertension, Combination Therapy, Fixed-Combination Dose
Medical subject headings: Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placeboDrug
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tabletsDrug
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tabletsDrug
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tabletsDrug
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks

Study groups in NCT00430508
Study group	Role	What they receive
4	Experimental	olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks Receives: Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo
1	Experimental	olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks Receives: Drug: olmesartan medoxomil/hydrochlorothiazide tablets
3	Experimental	olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks Receives: Drug: olmesartan medoxomil/hydrochlorothiazide tablets
2	Experimental	olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks Receives: Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16
Change = Week 16 - Week 8 (baseline).
Measured: 8 weeks, change = week 16 - week 8

Secondary outcomes (7)

Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.
Change = Week 12 - Week 8 (baseline).
Measured: 4 weeks, change = week 12 - week 8
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.
Change = Week 16 - Week 8 (baseline).
Measured: 8 weeks, change = week 16 - week 8
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.
Change = Week 12 - Week 8 (baseline).
Measured: 4 weeks, change = week 12 - week 8
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
Measured: 8 weeks
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).
Measured: 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.
Change = Week 16 - Week 8 (baseline).
Measured: 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.
Change = Week 16 - Week 8 (baseline).
Measured: 8 weeks, change = week 16 - week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007May 2008

First posted2 Feb 2007 (estimated)
Study startFeb 2007
Primary completionMar 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Essential HypertensionStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 972 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00430508
Sponsor's protocol ID: CS866CM-B-E301
Status last verified: Jun 2009
First submitted: 1 Feb 2007
Last updated: 9 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: 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/

Publications

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.
PubMed 22114906

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension

All Essential Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00430508
Acronym / sponsor ID: CS866CM-B-E301
Conditions: Essential Hypertension
Keywords: Moderate-to-Severe Hypertension, Essential Hypertension, Combination Therapy, Fixed-Combination Dose
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 972 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Collaborators: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Study start: Feb 2007
Primary completion: Mar 2008 (actual)
Study completion: May 2008 (actual)
First posted: 2 Feb 2007 (estimated)
Results: Posted 17 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
4	Experimental	Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placeboolmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1	Experimental	Drug: olmesartan medoxomil/hydrochlorothiazide tabletsolmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
3	Experimental	Drug: olmesartan medoxomil/hydrochlorothiazide tabletsolmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
2	Experimental	Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tabletsolmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (12 listed)

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:
Patients with clinically significant abnormal laboratory values at screening.
Patients with secondary HTN.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placeboolmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week	Drug	4
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tabletsolmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks	Drug	2
olmesartan medoxomil/hydrochlorothiazide tabletsolmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks	Drug	1
olmesartan medoxomil/hydrochlorothiazide tabletsolmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks	Drug	3

Primary outcome

Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16
Time frame: 8 weeks, change = week 16 - week 8
Change = Week 16 - Week 8 (baseline).

7 secondary outcomes

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

Results and safety

Results posted to the registry on 17 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo	140	137
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo	278	272
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo	279	266
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo	274	269

Primary outcome: Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16

Time frame: 8 weeks, change = week 16 - week 8. Mean (Standard Deviation). Unit: mm Hg

Measure	OM/HCTZ 40/25mg + 20/12.5 Matching Placebo n = 140	OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo n = 277	OM/HCTZ 20/12.5mg + 40/0 Matching Placebo n = 279	OM/HCTZ 40/0mg + 20/12.5 Matching Placebo n = 274
Value	-11.16 (8.796)	-9.13 (8.622)	-8.10 (7.968)	-5.66 (8.546)

OM/HCTZ 40/25mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo: Mean Difference (Net): -5.3 (95% CI -6.97 to -3.6), p <0.0001, ANCOVA
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 40/0mg + 20/12.5 Matching Placebo: Mean Difference (Net): -3.4 (95% CI -4.79 to -2.03), p <0.0001, ANCOVA
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo vs OM/HCTZ 20/12.5mg + 40/0 Matching Placebo: Mean Difference (Net): -0.9 (95% CI -2.32 to 0.43), p = 0.1788, ANCOVA

Population analysed: Full Analysis Set-Last Observation Carried Forward.

7 secondary outcomes are reported in the full results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22114906Rosenbaum 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.
Individual participant dataSharing planned: Yes. 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/

Related trials for Essential Hypertension

Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Professor Lars Christian Rump, M.D. study chair

University of Ruhr-Bochum

55 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Czechia, Poland, Germany, Ukraine, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16 (time frame: 8 weeks, change = week 16 - week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00430508, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.