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Essential HypertensionPhase 3NCT01838850

Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Combination Therapy in Patients With Hypertension Not Controlled With Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy

A Phase 3 study of Essential Hypertension, run by Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company at 39 sites in South Korea.

Completed

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

Official record
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Trial summary

CS-8635 combines three widely prescribed antihypertensive medications, olmesartan medoxomil(OM), amlodipine (AML), and hydrochlorothiazide (HCTZ), to lower blood pressure. The purpose of the study is to evaluate the efficacy and safety of triple therapy with CS-8635 compared with dual therapy in Korean patients with… Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Essential Hypertension
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
344 participants
Where
39 sitesSouth Korea
Study dates
Apr 2013to Aug 2014
Phase
Phase 3
Are there results?
None posted in the registry

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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female at the age of 20 to 75 years
  • Voluntary written informed consent to participation in this study
  • Patients with hypertension either newly diagnosed or without treatment of antihypertensive drugs within 4 weeks of screening, who have mean seated diastolic blood pressure (msDBP) ≥ 100 mmHg at screening, or
  • Patients who have been on a stable dose of antihypertensive drugs for at least 4 weeks before run-in period and meet the following blood pressure criteria at screening: Monotherapy: msDBP ≥ 95 mmHg, or Dual combination therapy: msDBP ≥ 90 mmHg, or Triple combination therapy: 70 mmHg ≤ msDBP < 90 mmHg
  • msSBP/DBP at randomization: msSBP ≥ 140 mmHg (msSBP ≥ 130 mmHg in subjects with diabetes or chronic renal disease), and msDBP ≥ 90 mmHg (msDBP ≥ 80 mmHg in subjects with diabetes or chronic renal disease)

Who cannot join

  • msDBP ≥ 115mmHg or msSBP ≥ 200 mmHg measured at screening and randomization
  • Patients with mini-max blood pressure difference of SeSBP ≥ 20 mmHg or SeDBP ≥ 10 mmHg in the chosen arm at screening
  • Patients with blood pressure difference of SeSBP ≥ 20 mmHg and SeDBP ≥ 10 mmHg in both arms at screening
  • Patients with hypersensitivity to the investigational product or any of its components
  • Patients with medical history or hypersensitivity to sulfonamide, dihydropyridine, or thiazide diuretics
  • History of secondary hypertension or history of any of the diseases suspected of secondary hypertension
Show all 25Show fewer
  • Symptomatic orthostatic hypotension
  • Uncontrolled diabetes mellitus
  • Severe heart disease, or ischemic heart disease, peripheral vascular disease
  • Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia considered clinically significant
  • Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant stenosis on aortic valve or mitral valve.
  • Severe cerebrovascular disorder
  • Known moderate or malignant retinopathy
  • Consumption disease , autoimmune disease, or connective tissue disease
  • Patients requiring chronic anti-inflammatory treatment
  • Anuria or severe renal failure
  • Severe hepatic failure, AST or ALT > 3 times the upper limit of normal, biliary obstruction, biliary cirrhosis, or cholestasis
  • Patients who have been treated for hyponatremia, hypokalemia, hyperkalemia, hypercalcemia, or symptomatic hyperuricemia
  • Addison's disease
  • Glucose-galactose malabsorption, galactose intolerance, or Lapp lactase deficiency
  • Gastrointestinal tract disease or surgical operation that may affect absorption, distribution, metabolism, and excretion of drugs, presence of active gastritis or gastrointestinal/rectal bleeding considered clinical significant by the investigator, active inflammatory bowel syndrome within the last 12 months, etc
  • Patients with history of or suspected of drug or alcohol abuse
  • Pregnant or lactating women, or women of childbearing potential who do not agree to use appropriate contraceptive methods such as progestin hormone therapy (Oral, implant), intrauterine device, barrier methods of contraception (condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide), male sterilisation or true abstinence
  • Patients who participated in other clinical study within 1 month prior to screening
  • Patients considered to be incapable of complying with the protocol

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

South Korea39 sites

  • Korea University Ansan Hospital

    Ansan, 425-707

  • Hallym University Medical Center

    Anyang, 431-796

  • Soonchunhyang University Hospital

    Bucheon-si, 420-767

  • Dong-A University Hospital

    Busan, 602-715

  • Pusan National University Hospital

    Busan, 602-739

  • Daedong Hospital

    Busan, 607-711

  • Inje University Haeundae Paik Hospital

    Busan, 612-896

  • Inje University Busan Paik Hospital

    Busan, 614-735

  • Chungbuk National University Hospital

    Cheongju-si, 361-711,

  • Presbyterian Medical Center

    Cheonju, 560-750

  • Chonbuk National University Hospital

    Cheonju, 561-712

  • Keimyung University Dongsan Medical Center

    Daegu, 700-712

  • Daegu Catholic University Medical Center

    Daegu, 705-718

  • Chungnam National University Hospital

    Daejeon, 301-721

  • Konyang University Hospital

    Daejeon, 302-718

  • Health Insurance Service Ilsan Hospital

    Goyang, 410-719

  • Hanyang University Guri Hospital

    Guri-si, 471-701

  • Chonnam National University Hospital

    Gwangju, 501-757

  • Gachon University Gil Medical Center

    Incheon, 405-835

  • Seoul National University Bundang Hospital

    Seongnam, 463-707

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital

    Seoul, 120-752

  • Kyung Hee University Medical Center

    Seoul, 130-702

  • Kyunghee University Hospital at Gandong

    Seoul, 134-727

  • Seoul Veterans Hospital

    Seoul, 134-791

  • Sanmsung Medical Center

    Seoul, 135-710

  • Gangnam Severance Hospital

    Seoul, 135-720

  • Korea University Anam Hospital

    Seoul, 136-705

  • Seoul St. Mary's Hospital of the Catholic University of Korea

    Seoul, 137-701

  • Asan Medical Center

    Seoul, 138-736

  • Eulji General Hospital

    Seoul, 139-711

  • Konkuk University Medical Center

    Seoul, 143-729

  • Yeouido St. Mary's Hospital of the Catholic University of Korea

    Seoul, 150-713

  • Korea University Guro Hospital

    Seoul, 152-840

  • Chung-Ang University Hospital

    Seoul, 156-755

  • St. Carollo Hospital

    Suncheon, 540-719

  • Ajou University Hospital

    Suwon, 443-380

  • Ulsan University hospital

    Ulsan, 682-714

  • Wonju Severance Christian Hospital

    Wŏnju, 220-701

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Triple Fixed Dose Combination Therapy With Olmesartan Medoxomil 20mg, Amlodipine 5mg and Hydrochlorothiazide 12.5mg in Patients With Hypertension Not Controlled With Dual Fixed Dose Combination Therapy With Olmesartan Medoxomil 20mg and Hydrochlorothiazide 12.5mg

CS-8635 combines three widely prescribed antihypertensive medications, olmesartan medoxomil(OM), amlodipine (AML), and hydrochlorothiazide (HCTZ), to lower blood pressure. The purpose of the study is to evaluate the efficacy and safety of triple therapy with CS-8635 compared with dual therapy in Korean patients with hypertension not controlled with dual fixed dose combination therapy (Olmetec® Plus). The treatments that will be used in this study are as follows: Run-in period -OM/HCTZ 20/12.5 mg (Olmetec® Plus 20/12.5 mg) ; Double blind treatment period - OM/AML/HCTZ 20/5/12.5mg (CS8635 20/5/12.5mg) + its matching placebo vs.OM/HCTZ 20/12.5mg (Olmetec® Plus 20/12.5 mg) + its matching placebo; Open label extension period - OM/AML/HCTZ 40/5/12.5mg (CS8635 40/5/12.5mg) or OM/AML/HCTZ 20/5/12.5mg (CS8635 20/5/12.5mg).

Read the detailed description

Please refer to arms, outcome measures and eligibility criteria for details.

Being tested
CS8635 20/5/12.5mg and placebo, Olmetec® Plus 20/12.5mg and placebo
Medical subject headings
Essential Hypertension

What participants receive

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

  • CS8635 20/5/12.5mg and placeboDrug

    Run-in period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, given once a day.

    Double-blind period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Amlodipine (AML)-Hydrochlorothiazide(HCTZ) 20-5-12.5mg, oral placebo tablet. All tablets are given once a day.

    Open-label period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Amlodipine(AML)-Hydrochlorothiazide(HCTZ) 40-5-12.5mg, given once a day.

  • Olmetec® Plus 20/12.5mg and placeboDrug

    Run-in period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, given once a day.

    Double-blind period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, oral placebo tablet. All tablets are given once a day.

    Open-label period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Amlodipine(AML)-Hydrochlorothiazide(HCTZ) 20-5-12.5mg, given once a day.

Study groups in NCT01838850
Study groupRoleWhat they receive
CS8635 20/5/12.5mg and placeboExperimentalParticipants receiving Olmetec® Plus 20/12.5mg (OM/HCTZ 20/12.5 mg) for the 4-week, Run-in Period but who do not meet their blood pressure goals(Non-responders) could start receiving this triple fixed dose combination therapy (CS8635 20/5/12.5mg (OM/AML/HCTZ 20/5/12.5mg) + placebo) in randomized, 8-week, double-blind Period. The non-responders finishing double-blind treatment could continue the 8-week Open-label Period with CS8635 40/5/12.5mg (OM/AML/HCTZ 40/5/12.5 mg).
Receives: Drug: CS8635 20/5/12.5mg and placebo
Olmetec® Plus 20/12.5mg and placeboActive comparatorParticipants receiving Olmetec® Plus 20/12.5mg (OM/HCTZ 20/12.5 mg) for the 4-week, Run-in Period but who do not meet their blood pressure goals(Non-responders) could start receiving this dual fixed dose combination therapy (Olmetec® Plus 20/12.5mg (OM/HCTZ 20/12.5mg) + Placebo) in randomized, 8-week, double-blind Period. The non-responders finishing double-blind treatment could continue the 8-week Open-label Period with CS8635 20/5/12.5mg (OM/AML/HCTZ 20/5/12.5 mg).
Receives: Drug: Olmetec® Plus 20/12.5mg and placebo

What is being measured

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

  1. The changes of seated diastolic blood pressure of the Triple Combinations OM/AML/HCTZ 20/5/12.5mg vs.OM/HCTZ 20/12.5mg

    Measured: from baseline to week 8

Secondary outcomes (5)

  1. The changes of mean seated systolic blood pressure of the Triple Combinations OM/AML/HCTZ 20/5/12.5mg vs.OM/HCTZ 20/12.5mg

    Measured: from baseline to Week 8

  2. The changes of mean seated systolic and diastolic blood pressure of the Triple Combinations OM/AML/HCTZ 20/5/12.5mg vs.OM/HCTZ 20/12.5mg

    Measured: from baseline to week 4

  3. Percentage of subjects achieving blood pressure goal of the Triple Combinations OM/AML/HCTZ 20/5/12.5mg vs.OM/HCTZ 20/12.5mg

    Measured: at Week 4, and Week 8

  4. Percentage of subjects achieving blood pressure goal of the Triple Combinations OM/AML/HCTZ 40/5/12.5mg vs.OM/AML/HCTZ 20/5/12.5mg

    Measured: At week 16

  5. The changes of mean seated systolic and diastolic blood pressure of the Triple Combinations OM/AML/HCTZ 40/5/12.5mg vs.OM/AML/HCTZ 20/5/12.5mg

    Measured: from Week 8 to Week 16

Timeline

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

  1. First posted24 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionAug 2014
  4. Study completionAug 2014

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01838850
Sponsor's protocol ID
CS8635-SIT-11-01
Status last verified
Aug 2017
First submitted
22 Apr 2013
Last updated
24 Dec 2018
Results posted
No
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

  • Sohn IS, Kim CJ, Oh BH, Hong TJ, Park CG, Kim BS, Chung WB; Investigators. Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Combination Therapy in Patients with Hypertension Not Controlled with Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy: Results of a Randomized, Double-Blind, Multicenter Trial. Am J Cardiovasc Drugs. 2016 Apr;16(2):129-38. doi: 10.1007/s40256-015-0156-x.

    PubMed 26691333

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Essential Hypertension, run by Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company at 39 sites in South Korea.

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 25 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 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 changes of seated diastolic blood pressure of the Triple Combinations OM/AML/HCTZ 20/5/12.5mg vs.OM/HCTZ 20/12.5mg (time frame: from baseline to week 8). 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 NCT01838850, which also lists 1 linked publication.

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 24 Dec 2018.

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