Essential HypertensionPhase 3NCT00902538
Hydrochlorothiazide as add-on to Olmesartan/Amlodipine in Hypertension
A Phase 3 study testing Olmesartan medoxomil 40 mg - Amlodipine 10 mg, Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mg and Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mg in people with Essential Hypertension, run by Daiichi Sankyo at 117 sites in 14 countries.
Trial summary
Both Olmesartan (OLM)/Amlodipine (AML) combination and Hydrochlorothiazide (HCTZ) have proven to be efficacious and safe in lowering blood pressure, but may not always be sufficient. 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 40 mg - Amlodipine 10 mg, Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mg and Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,204 participants
- Where
- 117 sitesin 14 countries
- Study dates
- Apr 2009to Oct 2010
- 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 aged 18 years or older.
- Mean trough seated systolic blood pressure (SeSBP) of ≥ 160/100 mmHg (SeSBP of ≥ 160 mmHg and seated diastolic blood pressure (SeDBP) ≥ 100 mmHg) at screening if not currently on antihypertensive medication (e.g. newly diagnosed subjects)
- OR:
- For subjects on monotherapy: mean trough SeSBP of ≥ 150/95 mmHg (SeSBP of ≥ 150 mmHg and SeDBP ≥ 95 mmHg) at screening
- OR:
- For subjects on any combination of antihypertensive medications that includes either hydrochlorothiazide or amlodipine or olmesartan for a duration of at least four weeks: mean trough SeSBP of ≥ 140/90 mmHg (SeSBP of ≥ 140 mmHg and SeDBP ≥ 90 mmHg) at screening
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- OR:
- For subjects on any other combination of antihypertensive medications that includes neither hydrochlorothiazide, amlodipine nor olmesartan: mean trough SeSBP ≥ 160 mmHg, mean trough SeDBP ≥ 100mmHg, at the end of the taper-off period
- Subject freely signs 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]). Females taking oral contraceptives should have been on therapy for at least three months. 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. If a female becomes pregnant during the study, she has to be withdrawn immediately.
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, haematological or oncological, neurological, 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
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- Gamma-glutamyltransferase (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 excipients.
- Subjects with a mean SeSBP > 200 mmHg or mean SeDBP > 115 mmHg or 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 2).
Trial locations and contacts
117 sites in 14 countries.
117 sites in 14 countries
France15 sites
Study site
Albi
Study site
Angers
Study site
Brest
Study site
Cambrai
Study site
Créteil
Study site
Dijon
Study site
Dinard
Study site
Lyon
Study site
Nancy
Study site
Pessac
Study site
Roubaix
Study site
Strasbourg
Study site
Tiercé
Study site
Vandœuvre-lès-Nancy
Study site
Villefranche-de-Rouergue
Spain12 sites
Study site
Alicante
Study site
Barcelona
Study site
Elche
Study site
Granada
Study site
La Gineta, Albacete
Study site
La Roda, Albacete
Study site
Madrid
Study site
Palma de Mallorca
Study site
Port de Sagunt, Valencia
Study site
Seville
Study site
Valencia
Study site
Vizcaya
Ukraine12 sites
Study site
Dnipropetrovsk
Study site
Donetsk
Study site
Ivano-Frankivsk
Study site
Kharkiv
Study site
Kiev
Study site
Lviv
Study site
Mykolayiv
Study site
Odesa
Study site
Simferopol
Study site
Uzhhorod
Study site
Vinnytsia
Study site
Yalta
Poland11 sites
Study site
Bytom
Study site
Gdansk
Study site
Katowice
Study site
Krakow
Study site
Piotrkow Trybunalski
Study site
Puławy
Study site
Siemianowice Śląskie
Study site
Tarnów
Study site
Torun
Study site
Warsaw
Study site
Wroclaw
Russia10 sites
Study site
Moscow
Study site
Novosibirsk
Study site
Orenburg
Study site
Ryazan
Study site
Saint Petersburg
Study site
Saratov
Study site
Smolensk
Study site
Tomsk
Study site
Yaroslavl
Study site
Yekaterinburg
Czechia9 sites
Study site
Bílovec
Study site
Brno
Study site
Havlíčkův Brod
Study site
Hodonín
Study site
Kladno
Study site
Kolín
Study site
Ostrava
Study site
Ostrava-Vitkovice
Study site
Prague
Germany9 sites
Study site
Berlin
Study site
Dresden
Study site
Einbeck
Study site
Hamburg
Study site
Magdeburg
Study site
München
Study site
Straßkirchen
Study site
Villingen-Schwenningen
Study site
Wermsdorf
Romania9 sites
Study site
Brasov
Study site
Bucharest
Study site
Cluj-Napoca
Study site
Iași
Study site
Oradea
Study site
Piteşti
Study site
Targoviste
Study site
Târgu Mureş
Study site
Timișoara
Belgium6 sites
Study site
Antwerp
Study site
Lauwe
Study site
Leuven
Study site
Liège
Study site
Massemen
Study site
Oostham
Netherlands6 sites
Study site
Almere Stad
Study site
Beek en Donk
Study site
Doetinchem
Study site
Groningen
Study site
Losser
Study site
Maastricht
Slovakia6 sites
Study site
Banska Bysterica
Study site
Brastislava
Study site
Dolný Kubín
Study site
Košice
Study site
Prešov
Study site
Šahy
Bulgaria5 sites
Study site
Haskovo
Study site
Pleven
Study site
Plovdiv
Study site
Sofia
Study site
Varna
Denmark4 sites
Study site
Copenhagen
Study site
Frederiksberg
Study site
Næstved
Study site
Roskilde
About this study
Official title: Add-on Study of Hydrochlorothiazide in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Olmesartan/Amlodipine Alone
Both Olmesartan (OLM)/Amlodipine (AML) combination and Hydrochlorothiazide (HCTZ) have proven to be efficacious and safe in lowering blood pressure, but may not always be sufficient. This study is to test efficacy and safety of the combination of OLM/AML and HCTZ in hypertensive patients whose blood pressure is not adequately controlled with OLM/AML alone. The following treatments will be included in the trial: OLM 40mg/AML 10mg; OLM 40mg/AML 10 mg/HCTZ 12.5 mg; OLM 40 mg/AML 10 mg/HCTZ 25 mg. The trial has four periods. The treatments that will be used are as follows:
Period 1 - OLM 40mg/AML 10mg; Period 2 - OLM 40mg/AML 10mg or OLM 40mg/AML 10 mg/HCTZ 12.5 mg or OLM 40 mg/AML 10 mg/HCTZ 25 mg; Period 3 - OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 - Period 3 responders: OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 - Period 3 non-responders: OLM 40mg/AML 10 mg/HCTZ 12.5 mg or OLM 40 mg/AML 10 mg/HCTZ 25 mg
- Conditions
- Essential Hypertension
- Being tested
- Olmesartan medoxomil 40 mg - Amlodipine 10 mg, Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mg, Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mg, OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg, OLM 40mg-AML 10mg-Hydrochlorothiazide 25mg
- Keywords
- Add on treatment, essential hypertension
- 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 40 mg - Amlodipine 10 mgDrug
Oral tablets containing Olmesartan medoxomil-Amlodipine 40-10 mg, given once daily
Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mgDrug
Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day.
Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mgDrug
Also called Olmesartan 40mg-Amlodipine 10mg tablet + 2 Hydrochlorothiazide 12.5mg tablets
Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 2 Hydrochlorothiazide 12.5mg oral tablets. All tablets are given once a day.
OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mgDrug
Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day.
OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mgDrug
Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day.
OLM 40mg-AML 10mg-Hydrochlorothiazide 25mgDrug
Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 2 Hydrochlorothiazide 12.5mg oral tablet. All tablets are given once a day.
| Study group | Role | What they receive |
|---|---|---|
| Olmesartan (OLM) 40mg-Amlodipine (AML) 10mg | Experimental | The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2. Receives: Drug: Olmesartan medoxomil 40 mg - Amlodipine 10 mg |
| Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mg | Experimental | Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3. Receives: Drug: Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mg |
| Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mg | Experimental | Participants could start receiving this combination in randomized, double-blind, 8- week Period 2. Receives: Drug: Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mg |
| OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg (Responders) | Experimental | Participants who meet their blood pressure goals in Period 3 and continued into the 8-week, double-blind Period 4 continued to receive this combination. Receives: Drug: OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg |
| OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg (Non-responders) | Experimental | Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4 Receives: Drug: OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg |
| OLM 40mg-AML 10mg-Hydrochlorothiazide 25mg (Non-responders) | Experimental | Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4 Receives: Drug: OLM 40mg-AML 10mg-Hydrochlorothiazide 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Seated Diastolic Blood Pressure (SeDBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg
Three cuff blood pressure measurements were taken at each visit.
Measured: baseline (8 weeks) to 16 weeks
Secondary outcomes (9)
Change in Seated Systolic Blood Pressure (SeSBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg
Three cuff blood pressure measurements were taken at each visit.
Measured: baseline (8 weeks) to week 16
Number of Subjects Achieving Blood Pressure (BP) Goal at Week 16.
Achieving blood pressure goal is defined as seated blood pressure <140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit.
Measured: baseline (week 8) to week 16
Change in 24-hour Diastolic Blood Pressure (DBP) Assessed by 24-hour Ambulatory Blood Pressure Measurement (ABPM).
Three cuff blood pressure measurements were taken at each visit.
Measured: Baseline (8 weeks) to 16 weeks
Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
Three cuff blood pressure measurements were taken at each visit.
Measured: Baseline (8 weeks) to 16 weeks
In Non-responders, the Change in Seated Diastolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.
Change in seated diastolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit.
Measured: week 24 to week 32
In Non-responders, the Change in Seated Systolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.
Change in seated systolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit.
Measured: week 24 to week 32
In Non-responders, the Number of Subject Meeting Their Blood Pressure Goals Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.
The number of non-responding participants who achieved their blood pressure goals at the end of Period 4. Achieving blood pressure goal is defined as seated blood pressure <140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit.
Measured: week 24 to week 32
In Non-responders, the Change in 24-hour Diastolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
In non-responders, the change in 24-hour diastolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4.
Measured: Week 16 to week 32
In Non-responders, the Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
In non-responders, the change in 24-hour systolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4.
Measured: Week 16 to week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2010
- Study completionOct 2010
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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2,204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902538
- Sponsor's protocol ID
- CS8635-A-E303
- Status last verified
- Feb 2012
- First submitted
- 13 May 2009
- Last updated
- 11 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/
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Add-on Study of Hydrochlorothiazide in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Olmesartan/Amlodipine Alone
- ClinicalTrials.gov ID
- NCT00902538
- Acronym / sponsor ID
- CS8635-A-E303
- Conditions
- Essential Hypertension
- Keywords
- Add on treatment, essential hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,204 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Posted 22 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Both Olmesartan (OLM)/Amlodipine (AML) combination and Hydrochlorothiazide (HCTZ) have proven to be efficacious and safe in lowering blood pressure, but may not always be sufficient. This study is to test efficacy and safety of the combination of OLM/AML and HCTZ in hypertensive patients whose blood pressure is not adequately controlled with OLM/AML alone. The following treatments will be included in the trial: OLM 40mg/AML 10mg; OLM 40mg/AML 10 mg/HCTZ 12.5 mg; OLM 40 mg/AML 10 mg/HCTZ 25 mg. The trial has four periods. The treatments that will be used are as follows:
Period 1 - OLM 40mg/AML 10mg; Period 2 - OLM 40mg/AML 10mg or OLM 40mg/AML 10 mg/HCTZ 12.5 mg or OLM 40 mg/AML 10 mg/HCTZ 25 mg; Period 3 - OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 - Period 3 responders: OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 - Period 3 non-responders: OLM 40mg/AML 10 mg/HCTZ 12.5 mg or OLM 40 mg/AML 10 mg/HCTZ 25 mg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Olmesartan (OLM) 40mg-Amlodipine (AML) 10mg | Experimental | Drug: Olmesartan medoxomil 40 mg - Amlodipine 10 mgThe participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2. |
| Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mg | Experimental | Drug: Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mgParticipants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3. |
| Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mg | Experimental | Drug: Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mgParticipants could start receiving this combination in randomized, double-blind, 8- week Period 2. |
| OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg (Responders) | Experimental | Drug: OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mgParticipants who meet their blood pressure goals in Period 3 and continued into the 8-week, double-blind Period 4 continued to receive this combination. |
| OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg (Non-responders) | Experimental | Drug: OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mgParticipants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4 |
| OLM 40mg-AML 10mg-Hydrochlorothiazide 25mg (Non-responders) | Experimental | Drug: OLM 40mg-AML 10mg-Hydrochlorothiazide 25mgParticipants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female aged 18 years or older.
- Mean trough seated systolic blood pressure (SeSBP) of ≥ 160/100 mmHg (SeSBP of ≥ 160 mmHg and seated diastolic blood pressure (SeDBP) ≥ 100 mmHg) at screening if not currently on antihypertensive medication (e.g. newly diagnosed subjects)
- For subjects on monotherapy: mean trough SeSBP of ≥ 150/95 mmHg (SeSBP of ≥ 150 mmHg and SeDBP ≥ 95 mmHg) at screening
- For subjects on any combination of antihypertensive medications that includes either hydrochlorothiazide or amlodipine or olmesartan for a duration of at least four weeks: mean trough SeSBP of ≥ 140/90 mmHg (SeSBP of ≥ 140 mmHg and SeDBP ≥ 90 mmHg) at screening
- For subjects on any other combination of antihypertensive medications that includes neither hydrochlorothiazide, amlodipine nor olmesartan: mean trough SeSBP ≥ 160 mmHg, mean trough SeDBP ≥ 100mmHg, at the end of the taper-off period
Key exclusion criteria (11 listed)
- 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, haematological or oncological, neurological, 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:
- Subjects with secondary hypertension of any aetiology such as renal disease, phaeochromocytoma, 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 40 mg - Amlodipine 10 mgOral tablets containing Olmesartan medoxomil-Amlodipine 40-10 mg, given once daily | Drug | Olmesartan (OLM) 40mg-Amlodipine (AML) 10mg |
| Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mgCoated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day. | Drug | Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mg |
| Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mgAlso: Olmesartan 40mg-Amlodipine 10mg tablet + 2 Hydrochlorothiazide 12.5mg tabletsCoated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 2 Hydrochlorothiazide 12.5mg oral tablets. All tablets are given once a day. | Drug | Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mg |
| OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mgCoated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day. | Drug | OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg (Responders) |
| OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mgCoated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day. | Drug | OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg (Non-responders) |
| OLM 40mg-AML 10mg-Hydrochlorothiazide 25mgCoated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 2 Hydrochlorothiazide 12.5mg oral tablet. All tablets are given once a day. | Drug | OLM 40mg-AML 10mg-Hydrochlorothiazide 25mg (Non-responders) |
Primary outcome
Change in Seated Diastolic Blood Pressure (SeDBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg
Time frame: baseline (8 weeks) to 16 weeks
Three cuff blood pressure measurements were taken at each visit.
9 secondary outcomes
Change in Seated Systolic Blood Pressure (SeSBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg
Time frame: baseline (8 weeks) to week 16
Number of Subjects Achieving Blood Pressure (BP) Goal at Week 16.
Time frame: baseline (week 8) to week 16
Change in 24-hour Diastolic Blood Pressure (DBP) Assessed by 24-hour Ambulatory Blood Pressure Measurement (ABPM).
Time frame: Baseline (8 weeks) to 16 weeks
Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
Time frame: Baseline (8 weeks) to 16 weeks
In Non-responders, the Change in Seated Diastolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.
Time frame: week 24 to week 32
In Non-responders, the Change in Seated Systolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.
Time frame: week 24 to week 32
In Non-responders, the Number of Subject Meeting Their Blood Pressure Goals Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.
Time frame: week 24 to week 32
In Non-responders, the Change in 24-hour Diastolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
Time frame: Week 16 to week 32
In Non-responders, the Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
Time frame: Week 16 to week 32
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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/
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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.
The record lists no contact. Use the official record to reach the sponsor.
117 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olmesartan medoxomil 40 mg - Amlodipine 10 mg, Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mg and Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mg in people with Essential Hypertension, run by Daiichi Sankyo at 117 sites in 14 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 10 inclusion and 11 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 11 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 117 sites in France, Spain, Ukraine, Poland, Russia and 9 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 22 Nov 2011). 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) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg (time frame: baseline (8 weeks) to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2019.