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NCT01838850

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

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

CS8635 20/5/12.5mg and placebo

Intervention Type DRUG

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 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).

Group Type ACTIVE_COMPARATOR

Olmetec® Plus 20/12.5mg and placebo

Intervention Type DRUG

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.

Interventions

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CS8635 20/5/12.5mg and placebo

Intervention Type DRUG

Olmetec® 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Role: PRINCIPAL_INVESTIGATOR

Daedong Hospital

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South Korea

References

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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.

Reference Type DERIVED

PMID: 26691333 (View on PubMed)

Other Identifiers

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CS8635-SIT-11-01

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

CS8635 20/5/12.5mg and placebo

CS8635 20/5/12.5mg and placebo

Olmetec® Plus 20/12.5mg and placebo

Olmetec® Plus 20/12.5mg and placebo

Interventions

CS8635 20/5/12.5mg and placebo

Olmetec® Plus 20/12.5mg and placebo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company

Responsible Party

Principal Investigators

Chang-Wook Nam

Cheol-Ho Kim

Sang-Hong Baek

Woo-Baek Chung

Woo-Shik Kim

Tae-Hoon Ahn

Jang-Hyun Cho

Byung-Hee Oh

Hweung-Kon Hwang

Chang-Gyu Park

Eun-Seok Shin

Dong-Ju Choi

Joon-Han Shin

Myung-Ho Jeong

Jin-Ok Jeong

Chong-Jin Kim

Jang-Ho Bae

Seung-Hwan Lee

Se-Joong Rim

Jay-Young Rhew

Doo-Il Kim

Dae-Kyeong Kim

Soon-Kil Kim

Hye-Sun Seo

Duk-Hyun Kang

Young-Dae Kim

Dong-Woon Kim

Taek-Jong Hong

Jong-Won Ha

Woo-Jung Park

Tae Ho Kim

Kee-Sik Kim

Seung-Woo Park

Wan-Joo Shim

Joo-Young Yang

Jae-Woong Choi

Sun-Hwa Lee

Jeong-Cheon Ahn

Keun Lee

Byung-Soo Kim

Locations

Korea University Ansan Hospital

Hallym University Medical Center

Soonchunhyang University Hospital

Dong-A University Hospital

Pusan National University Hospital

Daedong Hospital

Inje University Haeundae Paik Hospital

Inje University Busan Paik Hospital

Chungbuk National University Hospital

Presbyterian Medical Center

Chonbuk National University Hospital

Keimyung University Dongsan Medical Center

Daegu Catholic University Medical Center

Chungnam National University Hospital

Konyang University Hospital

Health Insurance Service Ilsan Hospital

Hanyang University Guri Hospital