CClinicalTrials.gg
Sign In
CompletedNCT01838850Updated Dec 24, 2018

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 interventional study of CS8635 20/5/12.5mg and placebo and Olmetec® Plus 20/12.5mg and placebo in Essential Hypertension, sponsored by Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company. Completed at 39 sites in Korea, Republic of. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-12-24.

Sponsored by Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
344
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Essential Hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 344 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

This is the only study on the registry with Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria for Screening

  • 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

Inclusion criteria for randomization

  • 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)

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
344 participants (actual)

Study arms

  • Experimental
    CS8635 20/5/12.5mg and placebo

    Participants 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).

    Drug: CS8635 20/5/12.5mg and placebo

  • Active comparator
    Olmetec® Plus 20/12.5mg and placebo

    Participants 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).

    Drug: Olmetec® Plus 20/12.5mg and placebo

Interventions

  • DrugCS8635 20/5/12.5mg and placebo

    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.

  • DrugOlmetec® Plus 20/12.5mg and placebo

    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.

06

What researchers measure

Primary outcomes

  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

    Time frame: from baseline to week 8

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: from Week 8 to Week 16

Other outcomes

  1. Collection of safety data from Adverse event, Laboratory test, Physical examination, Vital signs with pulse and ECG

    Time frame: from screening to Week 16

07

Study locations

39 sites
  • Korea University Ansan Hospital
    Ansan, 425-707, Korea, Republic of
  • Hallym University Medical Center
    Anyang, 431-796, Korea, Republic of
  • Soonchunhyang University Hospital
    Bucheon, 420-767, Korea, Republic of
  • Dong-A University Hospital
    Busan, 602-715, Korea, Republic of
  • Pusan National University Hospital
    Busan, 602-739, Korea, Republic of
  • Daedong Hospital
    Busan, 607-711, Korea, Republic of
  • Inje University Haeundae Paik Hospital
    Busan, 612-896, Korea, Republic of
  • Inje University Busan Paik Hospital
    Busan, 614-735, Korea, Republic of
  • Chungbuk National University Hospital
    Cheongju, 361-711,, Korea, Republic of
  • Presbyterian Medical Center
    Cheonju, 560-750, Korea, Republic of
  • Chonbuk National University Hospital
    Cheonju, 561-712, Korea, Republic of
  • Keimyung University Dongsan Medical Center
    Daegu, 700-712, Korea, Republic of
  • Daegu Catholic University Medical Center
    Daegu, 705-718, Korea, Republic of
  • Chungnam National University Hospital
    Daejeon, 301-721, Korea, Republic of
  • Konyang University Hospital
    Daejeon, 302-718, Korea, Republic of
  • Health Insurance Service Ilsan Hospital
    Goyang, 410-719, Korea, Republic of
  • Hanyang University Guri Hospital
    Guri, 471-701, Korea, Republic of
  • Chonnam National University Hospital
    Gwangju, 501-757, Korea, Republic of
  • Gachon University Gil Medical Center
    Incheon, 405-835, Korea, Republic of
  • Seoul National University Bundang Hospital
    Seongnam, 463-707, Korea, Republic of
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
  • Severance Hospital
    Seoul, 120-752, Korea, Republic of
  • Kyung Hee University Medical Center
    Seoul, 130-702, Korea, Republic of
  • Kyunghee University Hospital at Gandong
    Seoul, 134-727, Korea, Republic of
  • Seoul Veterans Hospital
    Seoul, 134-791, Korea, Republic of
  • Sanmsung Medical Center
    Seoul, 135-710, Korea, Republic of
  • Gangnam Severance Hospital
    Seoul, 135-720, Korea, Republic of
  • Korea University Anam Hospital
    Seoul, 136-705, Korea, Republic of
  • Seoul St. Mary's Hospital of the Catholic University of Korea
    Seoul, 137-701, Korea, Republic of
  • Asan Medical Center
    Seoul, 138-736, Korea, Republic of
  • Eulji General Hospital
    Seoul, 139-711, Korea, Republic of
  • Konkuk University Medical Center
    Seoul, 143-729, Korea, Republic of
  • Yeouido St. Mary's Hospital of the Catholic University of Korea
    Seoul, 150-713, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, 152-840, Korea, Republic of
  • Chung-Ang University Hospital
    Seoul, 156-755, Korea, Republic of
  • St. Carollo Hospital
    Suncheon, 540-719, Korea, Republic of
  • Ajou University Hospital
    Suwon, 443-380, Korea, Republic of
  • Ulsan University hospital
    Ulsan, 682-714, Korea, Republic of
  • Wonju Severance Christian Hospital
    Wonju, 220-701, Korea, Republic of
08

References and documents

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. Erratum In: Am J Cardiovasc Drugs. 2016 Apr;16(2):139. doi: 10.1007/s40256-016-0167-2. PubMed 26691333 ↗

Individual participant data

Plan to share: 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/

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01838850
Lead sponsor
Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company
Responsible party
Sponsor
First posted
Apr 24, 2013
Start date
Apr 2013
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Dec 24, 2018

Study contacts

Chang-Wook Nam
principal investigator · Keimyung University Dongsan Medical Center
Cheol-Ho Kim
principal investigator · Seoul National University Bundang Hospital
Sang-Hong Baek
principal investigator · Seoul St. Mary's Hospital of the Catholic University of Korea
Woo-Baek Chung
principal investigator · Yeouido St. Mary's Hospital of the Catholic University of Korea
Woo-Shik Kim
principal investigator · Kyunghee University Medical Center
Tae-Hoon Ahn
principal investigator · Gachon University Gil Medical Center
Jang-Hyun Cho
principal investigator · St. Carollo Hospital
Byung-Hee Oh
study chair · Seoul National Univerisity Hospital
Hweung-Kon Hwang
principal investigator · Konkuk University Medical Center
Chang-Gyu Park
principal investigator · Korea University Guro Hospital
Eun-Seok Shin
principal investigator · Ulsan University Hospital
Dong-Ju Choi
principal investigator · Seoul National University Bundang Hospital
Joon-Han Shin
principal investigator · Ajou University School of Medicine
Myung-Ho Jeong
principal investigator · Chonnam National University Hospital
Jin-Ok Jeong
principal investigator · Chungnam National University Hospital
Chong-Jin Kim
principal investigator · Kyunghee University Hospital at Gandong
Jang-Ho Bae
principal investigator · Konyang University Hospital
Seung-Hwan Lee
principal investigator · Wonju Severance Christian Hospital
Se-Joong Rim
principal investigator · Gangnam Severance Hospital
Jay-Young Rhew
principal investigator · Presbyterian medical center
Doo-Il Kim
principal investigator · Inje University
Dae-Kyeong Kim
principal investigator · Inje University
Soon-Kil Kim
principal investigator · Hanyang University
Hye-Sun Seo
principal investigator · Soonchunhyang University Hospital
Duk-Hyun Kang
principal investigator · Asan Medical Center
Young-Dae Kim
principal investigator · Dong-A University Hospital
Dong-Woon Kim
principal investigator · Chungbuk National University Hospital
Taek-Jong Hong
principal investigator · Pusan National University Hospital
Jong-Won Ha
principal investigator · Severance Hospital
Woo-Jung Park
principal investigator · Hallym University Medical Center
Tae Ho Kim
principal investigator · Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Kee-Sik Kim
principal investigator · Daegu Catholic University Medical Center
Seung-Woo Park
principal investigator · Sanmsung Medical Center
Wan-Joo Shim
principal investigator · Korea University Anam Hospital
Joo-Young Yang
principal investigator · Health Insurance Service Ilsan Hospital
Jae-Woong Choi
principal investigator · Eulji General Hospital
Sun-Hwa Lee
principal investigator · Chonbuk National University Hospital
Jeong-Cheon Ahn
principal investigator · Korea University
Keun Lee
principal investigator · Seoul Veterans Hospital
Byung-Soo Kim
principal investigator · Daedong Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypertension→

Start the discussion