Essential HypertensionPhase 4OLMETREATNCT00311155

Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension

A Phase 4 study testing olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary in people with Essential Hypertension, run by Sankyo Pharma Gmbh at 79 sites in 9 countries.

Completed

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

Official record

Search all trials

Trial summary

This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension. 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 + hydrochlorothiazide, if necessary + amlodipine, if necessary
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 694 participants
Where: 79 sitesin 9 countries
Study dates: Mar 2006to Apr 2008
Phase: Phase 4
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 and female patients age greater than or equal to 18 years with mild to moderate hypertension.
Pre-treated patients with normal or elevated blood pressure (BP) are eligible to participate if their pre-treatment medication can be withdrawn. At the end of the placebo run-in period sitting systolic BP greater than or equal to 140 and less than 180 mmHg and/or sitting diastolic BP greater than or equal to 90 and less than 110 mmHg at trough.

Who cannot join

Female patients of childbearing potential must not be pregnant or lactating and must be using adequate contraception.
Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cardiovascular, renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/oncological, neurological and psychiatric diseases.
Patients within the last 6 months having a history of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, cerebrovascular accident, or transient ischemic attack.
Patients with clinically significant elevations in laboratory values at Screening Visit.
Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome.
Patients with contraindications for olmesartan medoxomil, hydrochlorothiazide, and/or amlodipine besylate.

Trial locations and contacts

79 sites in 9 countries.

Country

City, postcode or hospital

79 sites in 9 countries

France14 sites

Study site
Ancerville, 55170
Study site
Bourges, 18000
Study site
Derval, 44590
Study site
Grenoble, 38100
Study site
Lille, 59037
Study site
Montrevel-en-Bresse, 01340
Study site
Pouilly-en-Auxois, 21320
Study site
Poussan, 34560
Study site
Saint-Aubin-des-Châteaux, 44110
Study site
Saint-Étienne-de-Montluc, 44360
Study site
Saint-Priest, 69800
Study site
Sorcy-Saint-Martin, 55190
Study site
Strasbourg, 67000
Study site
Yerres, 91330

Other trials in France

Germany14 sites

Study site
Annweiler am Trifels, 76855
Study site
Balve, 58802
Study site
Bammental, 69245
Ev. Krankenhaus Bielefeld, Medizinische Klinik in Bethel - Gilead I
Bielefeld, 33617
Uniklinik Bonn
Bonn, 53111
Study site
Goch, 47574
Study site
Haag, 83527
Study site
Hamburg, 20148
Study site
Heidelberg, 69115
Study site
Heidelberg (Neuenheim), 69120
Study site
Mühldorf / Inn, 84453
Study site
Schwenningen, 78054
Study site
VS-Villingen, 78050
Study site
Weyhe, 28844

Other trials in Germany

United Kingdom14 sites

The Atherstone Surgery
Atherstone, CV9 1EU
The Medical Centre
Birmingham, B37 7TR
Waterloo Medical Centre
Blackpool, FY4 3AD
Rowden Surgery
Chippenham, SN15 2SB
The Gables Medical Centre
Coventry, CV6 4DD
Bridge Medical Centre
Crawley, RH10 1LL
Homefield Surgery
Exeter, EX1 2QS
Woodside Health Centre
Glasgow, G20 7LR
Castle Milk Health Centre
Glasgow, G45 9 AW
Division of Cardiovascular and Endocrine Sciences
Manchester, M13 9NT
University of Manchester
Manchester, M13 9WL
Oakside Surgery
Plymouth, PL5 3PY
Norwood Medical Centre
Sheffield, S5 7HD
Lovemead Group Practice
Trowbridge, BA14 7EG

Other trials in United Kingdom

Italy13 sites

Ospedale Regina Apostolorum
Albano Laziale (RM), 00041
Ospedale C.G. Mazzoni
Ascoli Piceno, 63100
Ospedale Nuovo Cutroni
Barcellona Pozzo Di Gotto (ME), 98051
Casa di Cura "La Madonnina"
Bari, 70124
Ospedale San Sebastiano
Caserta, 81100
Ospedale Vittorio Emanuele
Catania, 95124
Università degli Studi "G. D'Annunzio"
Chieti Scalo, 66013
Azienda Ospedaliera "Madonna delle Grazie"
Matera, 75100
Ospedale San Paolo
Milan, 20142
Ospedale San Carlo Borromeo
Milan, 20153
Presidio Ospedaliero San Lorenzo
Palermo, 90146
Presidio Ospedaliero di Portogruaro
Portogruaro (VE), 30026
Azienda Policlinico Universitario a Gestione Diret
Udine, 33100

Other trials in Italy

Austria6 sites

Study site
Fulpmes, 6166
University Klinik, F. Innere Medizin
Innsbruck, 6020
Study site
Innsbruck, 6020
Study site
Kundl, 6250
Study site
Salzburg, 5020
Diakonissen-Krankenhaus Hospital
Salzburg-Aigen, 5026

Other trials in Austria

Netherlands6 sites

Study site
's-Hertogenbosch, 5216 GC
Maxima Medisch Centrum
Eindhoven, 5631 BM
H. Elvas
Elvas, 7350-954
Study site
Hilversum, 1214 JR
Study site
Lieshout, 5737 CB
Study site
Waalwijk, 5144 CB

Other trials in Netherlands

Switzerland5 sites

Zentrum Oberdorf
Affoltern am Albis, 8910
Study site
Bellinzona, 6500
Study site
Gland, 1196
Study site
Petit Lancy, 1213
Praxis Dreispitz
Zurich, 8050

Other trials in Switzerland

Belgium4 sites

Study site
Brussels, 1080
Study site
Mechelen, 2800
Centre Hospitalier du Bois de l'Abbaye et de Hesba, Department of Intensive Care
Seraing, 4100
Allgemeen Ziekenhuis Maria-Middelares, Cardiologie, Campus de Pelikaan
Temse, 9140

Other trials in Belgium

Portugal3 sites

H. Almada
Almada Almada, 2801-951
Hospital Fernando da Fonseca
Amadora Amadora, 2720-276
Hospital de. S. Marta
Lisboa Lisboa, 1169-024

Other trials in Portugal

About this study

Official title: Treat-to-Target Study of Olmesartan Medoxomil and an Add-on Treatment Algorithm Consisting of Hydrochlorothiazide and Amlodipine Besylate in Patients With Mild to Moderate Hypertension

This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.

Conditions: Essential Hypertension
Being tested: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary
Keywords: Olmesartan medoxomil, Hypertension
Medical subject headings: Essential Hypertension, Hypertension

What participants receive

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

olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessaryDrug
Olmesartan medoxomil oral tablets 20 mg for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 12.5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 10 mg for 4 weeks. All study medications are to be taken once daily. The subject's participation completes when blood pressure goals are achieved.

Study groups in NCT00311155
Study group	Role	What they receive
1	Experimental	Olmesartan medoxomil oral tablets for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets for 8 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets + amlodipine oral tablets for 8 weeks Receives: Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary

What is being measured

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

The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.
For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - <130 mm Hg; Diastolic - <80 mm Hg.
Measured: Baseline to ≤20 weeks

Secondary outcomes (5)

Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved
Normalized blood pressure is defined as a mean sitting systolic blood (sBP) pressure at trough of <140 mmHg and mean sitting diastolic blood pressure (dBP)of <90 mmHg for non-diabetic patients or a mean sitting sBP at trough of <130 mmHg and mean sitting dBP <80 mmHg for diabetic patients.
Measured: Baseline to ≤20 weeks
Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.
Diastolic responders were defined as a participant who is a normaliser or has a lowering of the mean sitting diastolic blood pressure of ≥10 mmHg at trough.
Measured: Baseline to ≤20 weeks
Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved
Systolic responders defined as a participant who is a normaliser or has a lowering of the mean sitting systolic blood pressure of ≥20 mmHg at trough
Measured: Baseline to ≤20 weeks
Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
Measured: Baseline to ≤20 weeks
Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
Measured: Baseline to ≤20 weeks

Timeline

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

Mar 2006Apr 2008

First posted5 Apr 2006 (estimated)
Study startMar 2006
Primary completionApr 2008
Study completionApr 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.
Other trials for Essential HypertensionStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 694 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00311155
Sponsor's protocol ID: SP-OLM-03-05
Other IDs: 2005-004659-36, 2005
Acronym: OLMETREAT
Status last verified: Nov 2010
First submitted: 3 Apr 2006
Last updated: 10 Dec 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treat-to-Target Study of Olmesartan Medoxomil and an Add-on Treatment Algorithm Consisting of Hydrochlorothiazide and Amlodipine Besylate in Patients With Mild to Moderate Hypertension
ClinicalTrials.gov ID: NCT00311155
Acronym / sponsor ID: OLMETREAT / SP-OLM-03-05
Conditions: Essential Hypertension
Keywords: Olmesartan medoxomil, Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 694 participants (actual)
Lead sponsor: Sankyo Pharma GmbhIndustry (pharma, biotech, devices)
Study start: Mar 2006
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 5 Apr 2006 (estimated)
Results: Posted 10 Nov 2010

Clinical summary

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

This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessaryOlmesartan medoxomil oral tablets for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets for 8 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets + amlodipine oral tablets 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 (2 listed)

Male and female patients age greater than or equal to 18 years with mild to moderate hypertension.
Pre-treated patients with normal or elevated blood pressure (BP) are eligible to participate if their pre-treatment medication can be withdrawn. At the end of the placebo run-in period sitting systolic BP greater than or equal to 140 and less than 180 mmHg and/or sitting diastolic BP greater than or equal to 90 and less than 110 mmHg at trough.

Key exclusion criteria (6 listed)

Female patients of childbearing potential must not be pregnant or lactating and must be using adequate contraception.
Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cardiovascular, renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/oncological, neurological and psychiatric diseases.
Patients within the last 6 months having a history of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, cerebrovascular accident, or transient ischemic attack.
Patients with clinically significant elevations in laboratory values at Screening Visit.
Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome.

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 + hydrochlorothiazide, if necessary + amlodipine, if necessaryOlmesartan medoxomil oral tablets 20 mg for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 12.5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 10 mg for 4 weeks. All study medications are to be taken once daily. The subject's participation completes when blood pressure goals are achieved.	Drug	1

Primary outcome

The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.
Time frame: Baseline to ≤20 weeks
For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - <130 mm Hg; Diastolic - <80 mm Hg.

5 secondary outcomes

Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved
Time frame: Baseline to ≤20 weeks
Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.
Time frame: Baseline to ≤20 weeks
Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved
Time frame: Baseline to ≤20 weeks
Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
Time frame: Baseline to ≤20 weeks
Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
Time frame: Baseline to ≤20 weeks

Results and safety

Results posted to the registry on 10 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed	694	601

Primary outcome: The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.

Time frame: Baseline to ≤20 weeks. Number. Unit: Percentage of participants

Measure	Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed n = 691
Overall N=691	71.8
OLM 20 mg N=688	12.3
OLM 20 mg+HCTZ 12.5 mg N=580	16.4
OLM 20 mg+HCTZ 25 mg N=446	19.2
OLM 20 mg+HCTZ 25 mg+AML 5 mg N=296	14.9
OLM 20 mg+HCTZ 25 mg+AML 10 mg N=176	8.5

Population analysed: 691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: The time frame was from baseline to up to 20 weeks of treatment. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed	7 of 694 (1%)	293 of 694 (42.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Anthony Heagerty, MD principal investigator

University of Manchester, Dept. of Medicine

79 sites in 9 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 2 inclusion and 6 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 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in France, Germany, United Kingdom, Italy, Austria and 4 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 10 Nov 2010). 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?

The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved. (time frame: Baseline to ≤20 weeks). 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 NCT00311155.

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 10 Dec 2010.