Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in Hypertension
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
1 other identifier
interventional
2,689
15 countries
133
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2009
133 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
June 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
April 6, 2012
CompletedJanuary 10, 2019
April 1, 2012
1.6 years
June 16, 2009
January 30, 2012
December 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Baseline to week 10
Secondary Outcomes (9)
Change in Seated Systolic Blood Pressure (SeDBP).
Baseline to week 10
Number of Subjects Reaching Blood Pressure Goal at Week 10
baseline to week 10
Change in Seated Diastolic Blood Pressure From Week 18 to Week 22
Week 18 to week 22
Change in Seated Systolic Blood Pressure From Week 18 to Week 22
Week 18 to week 22
Number of Subjects Reaching Blood Pressure Goal From Week 18 to Week 22
Week 18 to week 22
- +4 more secondary outcomes
Study Arms (8)
olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5mg
EXPERIMENTALolmesartan medoxomil 20mg / amlodipine besylate 5 mg / hydrochlorothiazide 12.5mg
olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5mg
EXPERIMENTALolmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/25mg
EXPERIMENTALolmesartan/amlodipine/hydrochlorothiazide 40mg/10mg/12.5mg
EXPERIMENTALolmesartan/amlodipine/hydrochlorothiazide 40mg/10mg/25mg
EXPERIMENTALolmesartan/amlodipine 20mg/5mg
EXPERIMENTALolmesartan medoxomil 20mg / amlodipine besylate 5mg
olmesartan/amlodipine 40mg/5mg
EXPERIMENTALolmesartan/amlodipine 40mg/10mg
EXPERIMENTALInterventions
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.
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.
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.
One olmesartan medoxomil 20 mg + amlodipine 5 mg combination oral tablet taken once per day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (133)
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Antwerp, Belgium
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Buizingen, Belgium
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De Pinte, Belgium
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Drongen, Belgium
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Ghent, Belgium
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Gilly, Belgium
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Merksem, Belgium
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Mouscron, Belgium
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Tremelo, Belgium
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Wichelen, Belgium
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Burgas, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Veliko Tarnovo, Bulgaria
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Benátky nad Jizerou, Czechia
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Brodce, Czechia
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Havířov, Czechia
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Jičín, Czechia
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Mladá Boleslav, Czechia
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Moravská Ostrava, Czechia
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Pilsen, Czechia
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Prachatice, Czechia
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Prague, Czechia
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Sokolov, Czechia
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Copenhagen, Denmark
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Frederiksberg, Denmark
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Roskilde, Denmark
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Berlin, Germany
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Cloppenburg, Germany
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Delitzsch, Germany
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Dresden, Germany
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Erfurt, Germany
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Essen, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Leipzig, Germany
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Northeim, Germany
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Simmern, Germany
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Wallerfing, Germany
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Wiesbaden, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Hódmezővásárhely, Hungary
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Jászberény, Hungary
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Kaposvár, Hungary
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Kecskemét, Hungary
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Orosháza, Hungary
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Pécs, Hungary
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Székesfehérvár, Hungary
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Veszprém, Hungary
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Zalaegerszeg, Hungary
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Bologna, Italy
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Brescia, Italy
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Chieti, Italy
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Ferrara, Italy
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Foggia, Italy
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Genova, Italy
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Palermo, Italy
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Parma, Italy
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Perugia, Italy
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Pisa, Italy
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Roma, Italy
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Sassari, Italy
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Stradella Pavia, Italy
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Cēsis, Latvia
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Daugavpils, Latvia
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Jēkabpils, Latvia
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Ogre, Latvia
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Riga, Latvia
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Tukums, Latvia
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Varakļāni, Latvia
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Ventspils, Latvia
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Deurne, Netherlands
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Eindhoven, Netherlands
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Lichtenvoorde, Netherlands
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Lieshout, Netherlands
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Rotterdam, Netherlands
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Utrecht, Netherlands
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Bialystok, Poland
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Dębica, Poland
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Gdansk, Poland
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Gdynia, Poland
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Jastrzebia Zdroj, Poland
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Krakow, Poland
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Lublin, Poland
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Mielec, Poland
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Opole, Poland
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Szczecin, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Arad, Romania
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Bucharest, Romania
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Craiova, Romania
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Iași, Romania
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Piteşti, Romania
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Ploieşti, Romania
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Sibiu, Romania
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Suceava, Romania
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Timișoara, Romania
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Barnaul, Russia
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Moscow, Russia
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Novosibirsk, Russia
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Saint Petersburg, Russia
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Tyumen, Russia
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Yaroslavl, Russia
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Banska Bysterica, Slovakia
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Bratilslava, Slovakia
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Nitra, Slovakia
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Považská Bystrica, Slovakia
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Rimavská Sobota, Slovakia
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Žilina, Slovakia
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Badalona, Spain
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Barcelona, Spain
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Ferrol, Spain
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Lleida, Spain
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Madrid, Spain
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Petrel, Spain
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Salamanca, Spain
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Santiago de Compostela, Spain
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Valencia, Spain
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Lutsk, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Simferopol, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhya, Ukraine
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Zhytomyr, Ukraine
Related Publications (3)
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.
PMID: 25879524DERIVEDVolpe 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.
PMID: 24760656DERIVEDVolpe 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.
PMID: 22909147DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bettina Ammentorp
- Organization
- Daiichi Sankyo Europe, GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2009
First Posted
June 18, 2009
Study Start
June 1, 2009
Primary Completion
January 1, 2011
Study Completion
March 1, 2011
Last Updated
January 10, 2019
Results First Posted
April 6, 2012
Record last verified: 2012-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- 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.
- 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.
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/