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

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Hypertension

Intervention: olmesartan medoxomil + amlodipine + hydroclororthiazide + placebo (Drug); Olmesartan medoxomil + amlodipine + hydrochlorothiazide + placebo (Drug); olmesartan medoxomil + amlodipine + hydroclororthiazide (Drug); olmesartan medoxomil + amlodipine + hydroclororthiazide (Drug); olmesartan medoxomil + amlodipine + hydroclororthiazide (Drug); olmesartan medoxomil + amlodipine (Drug); olmesartan medoxomil + amlodipine (Drug); olmesartan medoxomil + amlodipine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Daiichi Sankyo Inc.


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change in Seated Diastolic Blood Pressure (SeDBP).

Secondary outcome:

Change in Seated Systolic Blood Pressure (SeDBP).

Number of Subjects Reaching Blood Pressure Goal at Week 10

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

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

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

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

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

Number of Subjects Reaching Blood Pressure Goal at Week 26

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- 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. Exclusion Criteria:

- 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.

- 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


- 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.

Locations and Contacts

Antwerp, Belgium

Buizingen, Belgium

De Pinte, Belgium

Drongen, Belgium

Gent, Belgium

Gilly, Belgium

Merksem, Belgium

Mouscron, Belgium

Tremelo, Belgium

Wichelen, Belgium

Burgas, Bulgaria

Pleven, Bulgaria

Plovdiv, Bulgaria

Sofia, Bulgaria

Stara Zagora, Bulgaria

Veliko Tarnovo, Bulgaria

Benatky nad Jizerou, Czech Republic

Brodce, Czech Republic

Havirov, Czech Republic

Jicin, Czech Republic

Mlada Boleslav, Czech Republic

Moravska Ostrava, Czech Republic

Plzen, Czech Republic

Prachatice, Czech Republic

Praha, Czech Republic

Sokolov, Czech Republic

Copenhagen, Denmark

Frederiksberg, Denmark

Roskilde, Denmark

Berlin, Germany

Cloppenburg, Germany

Delitzsch, Germany

Dresden, Germany

Erfurt, Germany

Essen, Germany

Hamburg, Germany

Heidelberg, Germany

Leipzig, Germany

Northeim, Germany

Simmern, Germany

Wallerfing, Germany

Wiesbaden, Germany

Budapest, Hungary

Debrecen, Hungary

Hodmezovasarhely, Hungary

Jaszbereny, Hungary

Kaposvar, Hungary

Kecskemet, Hungary

Oroshaza, Hungary

Pecs, Hungary

Szekesfehervar, Hungary

Veszprem, Hungary

Zalaegerszeg, Hungary

Bologna, Italy

Brescia, Italy

Chieti, Italy

Ferrara, Italy

Foggia, Italy

Genova, Italy

Palermo, Italy

Parma, Italy

Perugia, Italy

Pisa, Italy

Roma, Italy

Sassari, Italy

Stradella Pavia, Italy

Cesis, Latvia

Daugavpils, Latvia

Jekabpils, Latvia

Ogre, Latvia

Riga, Latvia

Tukums, Latvia

Varaklani, Latvia

Ventspils, Latvia

Deurne, Netherlands

Eindhoven, Netherlands

Lichtenvoorde, Netherlands

Lieshout, Netherlands

Rotterdam, Netherlands

Utrecht, Netherlands

Bialystok, Poland

Debica, Poland

Gdansk, Poland

Gdynia, Poland

Jastrzebia Zdroj, Poland

Krakow, Poland

Lublin, Poland

Mielec, Poland

Opole, Poland

Szczecin, Poland

Warsaw, Poland

Wroclaw, Poland

Arad, Romania

Bucharest, Romania

Craiova, Romania

Iasi, Romania

Pitesti, Romania

Ploiesti, Romania

Sibiu, Romania

Suceava, Romania

Timisoara, Romania

Barnaul, Russian Federation

Moscow, Russian Federation

Novosibirsk, Russian Federation

Saint Petersburg, Russian Federation

Tyumen, Russian Federation

Yaroslavl, Russian Federation

Banska Bysterica, Slovakia

Bratilslava, Slovakia

Nitra, Slovakia

Povazska Bystrica, Slovakia

Rimavska Sobota, Slovakia

Zilina, Slovakia

Badalona, Spain

Barcelona, Spain

Ferrol, Spain

Lleida, Spain

Madrid, Spain

Petrer, Spain

Salamanca, Spain

Santiago de Compostela, Spain

Valencia, Spain

Dnipropetrovsk, Ukraine

Donetsk, Ukraine

Kharkiv, Ukraine

Kyiv, Ukraine

Lutsk, Ukraine

Lviv, Ukraine

Odesa, Ukraine

Simferopol, Ukraine

Vinnytsya, Ukraine

Zaporizhzhya, Ukraine

Zhytomyr, Ukraine

Additional Information

Starting date: June 2009
Last updated: April 6, 2012

Page last updated: August 23, 2015

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