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AzTrials

Essential HypertensionPhase 3NCT00923091

Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in Hypertension

A Phase 3 study testing olmesartan medoxomil + amlodipine + hydroclororthiazide and olmesartan medoxomil + amlodipine in people with Essential Hypertension, run by Daiichi Sankyo at 133 sites in 15 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 determine the change in blood pressure from the administration of Olmesartan/Amlodipine/Hydrochlorothiazide triple combinations compared to dual combinations with Olmesartan/Amlodipine. 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 + amlodipine + hydroclororthiazide and olmesartan medoxomil + amlodipine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,689 participants
Where
133 sitesin 15 countries
Study dates
Jun 2009to Mar 2011
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 subjects aged 18 years or older.
  • Subjects with mean trough seated blood pressure (SeBP) ≥ 160/100 mmHg, (seated systolic blood pressure(SeSBP) ≥ 160 mmHg and seated diastolic blood pressure (SeDBP) ≥ 100 mmHg) at Screening if not currently on antihypertensive medication (newly diagnosed subjects or subjects who are not taking any antihypertensive medication for at least 3 weeks); Or Subjects with mean trough SeBP ≥ 160/100 mmHg, SeSBP ≥ 160 mmHg and SeDBP ≥ 100 mmHg) after washout of prior antihypertensive medication in subjects who discontinued their previous antihypertensive medication.
  • The difference in mean SeSBP/SeDBP between the visit prior to randomisation and the randomisation visit must be ≤ 20/10 mmHg. Subjects not currently on antihypertensive (HTN) medication may meet this requirement at the screening visit (Visit 1) and the randomization visit (Visit 3). Subjects washing out of HTN medication must meet this requirement at least by Visit 2 (or Visit 2.1, if needed) and Visit 3. All subjects undergoing washout of their prior antihypertensive medication will have the opportunity to re-visit the study sites for additional visits during washout (Visits 2 and 2.1) to assess eligibility for randomisation.
  • Subjects freely sign the informed consent form (ICF) after the nature of the study and the disclosure of his/her data has been explained.
  • Female subjects of childbearing potential must be using adequate contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilised, or has not had a hysterectomy at least three months prior to the start of this study [Visit 1]). Adequate contraceptives include hormonal intra-uterine devices, hormonal contraceptives (oral, depot, patch or injectable), and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.

Who cannot join

  • Female subjects of childbearing potential who are pregnant or lactating.
  • Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of the investigational products, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematologic or, neurologic, and psychiatric diseases. The same applies for immunocompromised and/or neutropenic subjects.
  • Subjects having a history of the following within the last six months: myocardial infarction (MI), unstable angina pectoris, percutaneous coronary intervention, heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke), or transient ischaemic attack.
  • Subjects with clinically significant abnormal laboratory values at Screening, including subjects with one or more of the following:
  • Aspartate aminotransferase (AST) > 3 times upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) > 3 times ULN.
Show all 32Show fewer
  • Gamma-glutamyl transferase (GGT) > 3 times ULN.
  • Potassium above ULN (unless high value is due to haemolytic blood sample).
  • Subjects with secondary hypertension of any aetiology such as renal disease, phaeochromocytoma, or Cushing's syndrome.
  • Subjects with contraindication to olmesartan, amlodipine, hydrochlorothiazide, or any of the tablet's excipients.
  • Newly diagnosed subjects with a mean trough SeSBP > 200 mmHg or mean trough SeDBP > 115 mmHg or any subjects with bradycardia (heart rate < 50 beats/min at rest documented by mean radial pulse rate [PR] or electrocardiogram [ECG]) at Screening (Visit 1) or immediately before taking Period I study medication (Visit 3).
  • Subjects already taking four or more antihypertensive medications.
  • Subjects with a mean trough SeSBP > 145 mmHg or mean trough SeDBP > 95 mmHg while taking three antihypertensive medications.
  • Subjects with a mean trough SeSBP > 160 mmHg or mean trough SeDBP > 100 mmHg while taking two antihypertensive medications.
  • Subjects with a mean trough SeSBP > 180 mmHg or mean trough SeDBP > 110 mmHg while taking one antihypertensive medication.
  • Subjects with electrocardiogram evidence of 2nd or 3rd degree atrio ventricular (AV) block, atrial fibrillation, or other cardiac arrhythmia (requiring treatment).
  • Subjects with severe heart failure (New York Heart Association stage III-IV), clinically significant aortic or mitral valve stenosis, uncorrected coarctation of the aorta, obstruction of cardiac outflow (obstructive, hypertrophic cardiomyopathy) or symptomatic coronary disease.
  • Subjects with clinical evidence of renal disease including reno-vascular occlusive disease, nephrectomy and/or renal transplant, bilateral renal artery stenosis, unilateral renal artery stenosis in a solitary kidney, or severe renal impairment as evidenced by CrCl of < 30 mL/min calculated using the Cockcroft and Gault formula.
  • Subjects with clinically relevant hepatic impairment.
  • Subjects with biliary obstruction.
  • Subjects with uncontrolled Type 1 or Type 2 diabetes defined as HbA1c > 9.0%. Diabetics must have documentation of HbA1c within 6 months of the Screening Visit, or must have their HbA1c assessed prior to randomisation. Note: subjects with Type 1 or Type 2 diabetes controlled with insulin, diet or oral hypoglycaemic agents on a stable dose for at least 30 days may be included.
  • Subjects with a history of a wasting disease (e.g. cancer), autoimmune diseases, connective tissue diseases, major allergies or angioneurotic oedema.
  • Subjects who require or are taking any concomitant medication which may interfere with the objectives of the study.
  • Subjects on beta blockers or calcium channel blockers (CCBs) for both hypertension and either ischemia, post-MI prophylaxis or tachyarrhythmias.
  • Subjects with known malabsorption syndromes.
  • Subjects with psychiatric or emotional problems, which would invalidate the giving of informed consent or limit the ability of the subject to comply with study requirements.
  • Subjects with a history of alcohol and/or drug abuse.
  • Subjects who have received any investigational agent within 30 days prior to Screening.
  • Subjects who are unwilling or unable to provide informed consent or to participate satisfactorily for the entire study.
  • Subjects with malignancy during the past 2 years excluding squamous cell or basal cell carcinoma of the skin.
  • Subjects with signs or symptoms which could exacerbate the occurrence of hypotension such as volume and salt depletion.
  • Subjects with any medical condition, which in the judgment of the Investigator would jeopardise the evaluation of efficacy or safety and/or constitute a significant safety risk to the subject.

Trial locations and contacts

133 sites in 15 countries.

133 sites in 15 countries

Germany13 sites

  • Study site

    Berlin

  • Study site

    Cloppenburg

  • Study site

    Delitzsch

  • Study site

    Dresden

  • Study site

    Erfurt

  • Study site

    Essen

  • Study site

    Hamburg

  • Study site

    Heidelberg

  • Study site

    Leipzig

  • Study site

    Northeim

  • Study site

    Simmern

  • Study site

    Wallerfing

  • Study site

    Wiesbaden

Other trials in Germany

Italy13 sites

  • Study site

    Bologna

  • Study site

    Brescia

  • Study site

    Chieti

  • Study site

    Ferrara

  • Study site

    Foggia

  • Study site

    Genova

  • Study site

    Palermo

  • Study site

    Parma

  • Study site

    Perugia

  • Study site

    Pisa

  • Study site

    Roma

  • Study site

    Sassari

  • Study site

    Stradella Pavia

Other trials in Italy

Poland12 sites

  • Study site

    Bialystok

  • Study site

    Dębica

  • Study site

    Gdansk

  • Study site

    Gdynia

  • Study site

    Jastrzebia Zdroj

  • Study site

    Krakow

  • Study site

    Lublin

  • Study site

    Mielec

  • Study site

    Opole

  • Study site

    Szczecin

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Hungary11 sites

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Hódmezővásárhely

  • Study site

    Jászberény

  • Study site

    Kaposvár

  • Study site

    Kecskemét

  • Study site

    Orosháza

  • Study site

    Pécs

  • Study site

    Székesfehérvár

  • Study site

    Veszprém

  • Study site

    Zalaegerszeg

Other trials in Hungary

Ukraine11 sites

  • Study site

    Dnipropetrovsk

  • Study site

    Donetsk

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Lutsk

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Simferopol

  • Study site

    Vinnytsia

  • Study site

    Zaporizhzhya

  • Study site

    Zhytomyr

Other trials in Ukraine

Belgium10 sites

  • Study site

    Antwerp

  • Study site

    Buizingen

  • Study site

    De Pinte

  • Study site

    Drongen

  • Study site

    Ghent

  • Study site

    Gilly

  • Study site

    Merksem

  • Study site

    Mouscron

  • Study site

    Tremelo

  • Study site

    Wichelen

Other trials in Belgium

Czechia10 sites

  • Study site

    Benátky nad Jizerou

  • Study site

    Brodce

  • Study site

    Havířov

  • Study site

    Jičín

  • Study site

    Mladá Boleslav

  • Study site

    Moravská Ostrava

  • Study site

    Pilsen

  • Study site

    Prachatice

  • Study site

    Prague

  • Study site

    Sokolov

Other trials in Czechia

Romania9 sites

  • Study site

    Arad

  • Study site

    Bucharest

  • Study site

    Craiova

  • Study site

    Iași

  • Study site

    Piteşti

  • Study site

    Ploieşti

  • Study site

    Sibiu

  • Study site

    Suceava

  • Study site

    Timișoara

Other trials in Romania

Spain9 sites

  • Study site

    Badalona

  • Study site

    Barcelona

  • Study site

    Ferrol

  • Study site

    Lleida

  • Study site

    Madrid

  • Study site

    Petrel

  • Study site

    Salamanca

  • Study site

    Santiago de Compostela

  • Study site

    Valencia

Other trials in Spain

Latvia8 sites

  • Study site

    Cēsis

  • Study site

    Daugavpils

  • Study site

    Jēkabpils

  • Study site

    Ogre

  • Study site

    Riga

  • Study site

    Tukums

  • Study site

    Varakļāni

  • Study site

    Ventspils

Other trials in Latvia

Bulgaria6 sites

  • Study site

    Burgas

  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Sofia

  • Study site

    Stara Zagora

  • Study site

    Veliko Tarnovo

Other trials in Bulgaria

Netherlands6 sites

  • Study site

    Deurne

  • Study site

    Eindhoven

  • Study site

    Lichtenvoorde

  • Study site

    Lieshout

  • Study site

    Rotterdam

  • Study site

    Utrecht

Other trials in Netherlands

Russia6 sites

  • Study site

    Barnaul

  • Study site

    Moscow

  • Study site

    Novosibirsk

  • Study site

    Saint Petersburg

  • Study site

    Tyumen

  • Study site

    Yaroslavl

Other trials in Russia

Slovakia6 sites

  • Study site

    Banska Bysterica

  • Study site

    Bratilslava

  • Study site

    Nitra

  • Study site

    Považská Bystrica

  • Study site

    Rimavská Sobota

  • Study site

    Žilina

Other trials in Slovakia

Denmark3 sites

  • Study site

    Copenhagen

  • Study site

    Frederiksberg

  • Study site

    Roskilde

Other trials in Denmark

About this study

Official title: Randomised, Double-Blind, Parallel-Group Study Evaluating Efficacy and Safety of Co-Administration of Triple Combinations of Olmesartan Medoxomil, Amlodipine Besylate, and Hydrochlorothiazide Compared With Corresponding Olmesartan - Amlodipine Combination in Subjects With Hypertension

This study is to determine the change in blood pressure from the administration of Olmesartan/Amlodipine/Hydrochlorothiazide triple combinations compared to dual combinations with Olmesartan/Amlodipine.

Being tested
olmesartan medoxomil + amlodipine + hydroclororthiazide + placebo, Olmesartan medoxomil + amlodipine + hydrochlorothiazide + placebo, olmesartan medoxomil + amlodipine + hydroclororthiazide, olmesartan medoxomil + amlodipine
Keywords
triple combination, parallel group, dual combination
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 + amlodipine + hydroclororthiazide + placeboDrug

    Also called Azor

    One olmesartan medoxomil 20 mg + amlodipine 5 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.

  • Olmesartan medoxomil + amlodipine + hydrochlorothiazide + placeboDrug

    Also called Azor

    One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.

  • olmesartan medoxomil + amlodipine + hydroclororthiazideDrug

    Also called Azor, Norvasc

    One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day. Two hydrochlorothiazide 12.5 mg tablets taken once per day.

  • olmesartan medoxomil + amlodipine + hydroclororthiazideDrug

    Also called Azor

    One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.

  • olmesartan medoxomil + amlodipine + hydroclororthiazideDrug

    Also called Azor

    One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day. Two hydrochlorothiazide 12.5 mg tablets taken once per day.

  • olmesartan medoxomil + amlodipineDrug

    Also called Azor

    One olmesartan medoxomil 20 mg + amlodipine 5 mg combination oral tablet taken once per day

  • olmesartan medoxomil + amlodipineDrug

    One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day.

  • olmesartan medoxomil + amlodipineDrug

    Also called Azor

    One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day.

Study groups in NCT00923091
Study groupRoleWhat they receive
olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5mgExperimentalolmesartan medoxomil 20mg / amlodipine besylate 5 mg / hydrochlorothiazide 12.5mg
Receives: Drug: olmesartan medoxomil + amlodipine + hydroclororthiazide + placebo
olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5mgExperimentalNot described
Receives: Drug: Olmesartan medoxomil + amlodipine + hydrochlorothiazide + placebo
olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/25mgExperimentalNot described
Receives: Drug: olmesartan medoxomil + amlodipine + hydroclororthiazide
olmesartan/amlodipine/hydrochlorothiazide 40mg/10mg/12.5mgExperimentalNot described
Receives: Drug: olmesartan medoxomil + amlodipine + hydroclororthiazide
olmesartan/amlodipine/hydrochlorothiazide 40mg/10mg/25mgExperimentalNot described
Receives: Drug: olmesartan medoxomil + amlodipine + hydroclororthiazide
olmesartan/amlodipine 20mg/5mgExperimentalolmesartan medoxomil 20mg / amlodipine besylate 5mg
Receives: Drug: olmesartan medoxomil + amlodipine
olmesartan/amlodipine 40mg/5mgExperimentalNot described
Receives: Drug: olmesartan medoxomil + amlodipine
olmesartan/amlodipine 40mg/10mgExperimentalNot described
Receives: Drug: olmesartan medoxomil + amlodipine

What is being measured

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

  1. Change in Seated Diastolic Blood Pressure (SeDBP).

    Baseline blood pressure was defined as the average values obtained at the randomization visit and at the visit prior to randomization

    Measured: Baseline to week 10

Secondary outcomes (9)

  1. Change in Seated Systolic Blood Pressure (SeDBP).

    Measured: Baseline to week 10

  2. Number of Subjects Reaching Blood Pressure Goal at Week 10

    Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.

    Measured: baseline to week 10

  3. Change in Seated Diastolic Blood Pressure From Week 18 to Week 22

    Measured: Week 18 to week 22

  4. Change in Seated Systolic Blood Pressure From Week 18 to Week 22

    Measured: Week 18 to week 22

  5. Number of Subjects Reaching Blood Pressure Goal From Week 18 to Week 22

    Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.

    Measured: Week 18 to week 22

  6. Change in Seated Diastolic Blood Pressure From Week 22 to Week 26

    Measured: Week 22 to week 26

  7. Change in Seated Systolic Blood Pressure From Week 22 to Week 26

    Measured: Week 22 to week 26

  8. Number of Subjects Reaching Blood Pressure Goal at Week 26

    Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.

    Measured: Week 22 to week 26

  9. Change in Seated Systolic Blood Pressure (SeDBP) During Open-Label Period VI (Titration Effect From OM/AML/HCTZ 40/5/25 to 40/10/25.

    Measured: Week 26 to week 54

Timeline

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

  1. First posted18 Jun 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionJan 2011
  4. Study completionMar 2011

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2,689 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00923091
Sponsor's protocol ID
CS8635-A-E302
Status last verified
Apr 2012
First submitted
16 Jun 2009
Last updated
10 Jan 2019
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

  • Marques da Silva P, Haag U, Guest JF, Brazier JE, Soro M. Health-related quality of life impact of a triple combination of olmesartan medoxomil, amlodipine besylate and hydrochlorotiazide in subjects with hypertension. Health Qual Life Outcomes. 2015 Feb 21;13:24. doi: 10.1186/s12955-015-0216-6.

    PubMed 25879524

  • Volpe M, de la Sierra A, Ammentorp B, Laeis P. Open-label study assessing the long-term efficacy and safety of triple olmesartan/amlodipine/hydrochlorothiazide combination therapy for hypertension. Adv Ther. 2014 May;31(5):561-74. doi: 10.1007/s12325-014-0117-9. Epub 2014 Apr 24.

    PubMed 24760656

  • Volpe M, Christian Rump L, Ammentorp B, Laeis P. Efficacy and safety of triple antihypertensive therapy with the olmesartan/amlodipine/hydrochlorothiazide combination. Clin Drug Investig. 2012 Oct 1;32(10):649-64. doi: 10.1007/BF03261919.

    PubMed 22909147

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing olmesartan medoxomil + amlodipine + hydroclororthiazide and olmesartan medoxomil + amlodipine in people with Essential Hypertension, run by Daiichi Sankyo at 133 sites in 15 countries.

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 5 inclusion and 32 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 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 133 sites in Germany, Italy, Poland, Hungary, Ukraine and 10 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 6 Apr 2012). 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 Seated Diastolic Blood Pressure (SeDBP). (time frame: Baseline to week 10). 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 NCT00923091, which also lists 3 linked publications.

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 Jan 2019.

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