Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 82 of 134 for:    OLMESARTAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01838850
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company )

Brief 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).

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: CS8635 20/5/12.5mg and placebo Drug: Olmetec® Plus 20/12.5mg and placebo Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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.


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

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.





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838850


Locations
Layout table for location information
Korea, Republic of
Korea University Ansan Hospital
Ansan, Korea, Republic of, 425-707
Hallym University Medical Center
Anyang, Korea, Republic of, 431-796
Soonchunhyang University Hospital
Bucheon, Korea, Republic of, 420-767
Dong-A University Hospital
Busan, Korea, Republic of, 602-715
Pusan National University Hospital
Busan, Korea, Republic of, 602-739
Daedong Hospital
Busan, Korea, Republic of, 607-711
Inje University Haeundae Paik Hospital
Busan, Korea, Republic of, 612-896
Inje University Busan Paik Hospital
Busan, Korea, Republic of, 614-735
Chungbuk National University Hospital
Cheongju, Korea, Republic of, 361-711,
Presbyterian Medical Center
Cheonju, Korea, Republic of, 560-750
Chonbuk National University Hospital
Cheonju, Korea, Republic of, 561-712
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, 700-712
Daegu Catholic University Medical Center
Daegu, Korea, Republic of, 705-718
Chungnam National University Hospital
Daejeon, Korea, Republic of, 301-721
Konyang University Hospital
Daejeon, Korea, Republic of, 302-718
Health Insurance Service Ilsan Hospital
Goyang, Korea, Republic of, 410-719
Hanyang University Guri Hospital
Guri, Korea, Republic of, 471-701
Chonnam National University Hospital
Gwangju, Korea, Republic of, 501-757
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405-835
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 463-707
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Severance Hospital
Seoul, Korea, Republic of, 120-752
Kyung Hee University Medical Center
Seoul, Korea, Republic of, 130-702
Kyunghee University Hospital at Gandong
Seoul, Korea, Republic of, 134-727
Seoul Veterans Hospital
Seoul, Korea, Republic of, 134-791
Sanmsung Medical Center
Seoul, Korea, Republic of, 135-710
Gangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
Seoul St. Mary's Hospital of the Catholic University of Korea
Seoul, Korea, Republic of, 137-701
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Eulji General Hospital
Seoul, Korea, Republic of, 139-711
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Yeouido St. Mary's Hospital of the Catholic University of Korea
Seoul, Korea, Republic of, 150-713
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-840
Chung-Ang University Hospital
Seoul, Korea, Republic of, 156-755
St. Carollo Hospital
Suncheon, Korea, Republic of, 540-719
Ajou University Hospital
Suwon, Korea, Republic of, 443-380
Ulsan University hospital
Ulsan, Korea, Republic of, 682-714
Wonju Severance Christian Hospital
Wonju, Korea, Republic of, 220-701
Sponsors and Collaborators
Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company
Investigators
Layout table for investigator information
Principal Investigator: Chang-Wook Nam Keimyung University Dongsan Medical Center
Principal Investigator: Cheol-Ho Kim Seoul National University Bundang Hospital
Principal Investigator: Sang-Hong Baek Seoul St. Mary's Hospital of the Catholic University of Korea
Principal Investigator: Woo-Baek Chung Yeouido St. Mary's Hospital of the Catholic University of Korea
Principal Investigator: Woo-Shik Kim Kyunghee University Medical Center
Principal Investigator: Tae-Hoon Ahn Gachon University Gil Medical Center
Principal Investigator: Jang-Hyun Cho St. Carollo Hospital
Study Chair: Byung-Hee Oh Seoul National Univerisity Hospital
Principal Investigator: Hweung-Kon Hwang Konkuk University Medical Center
Principal Investigator: Chang-Gyu Park Korea University Guro Hospital
Principal Investigator: Eun-Seok Shin Ulsan University Hospital
Principal Investigator: Dong-Ju Choi Seoul National University Bundang Hospital
Principal Investigator: Joon-Han Shin Ajou University School of Medicine
Principal Investigator: Myung-Ho Jeong Chonnam National University Hospital
Principal Investigator: Jin-Ok Jeong Chungnam National University Hospital
Principal Investigator: Chong-Jin Kim Kyunghee University Hospital at Gandong
Principal Investigator: Jang-Ho Bae Konyang University Hospital
Principal Investigator: Seung-Hwan Lee Wonju Severance Christian Hospital
Principal Investigator: Se-Joong Rim Gangnam Severance Hospital
Principal Investigator: Jay-Young Rhew Presbyterian medical center
Principal Investigator: Doo-Il Kim Inje University
Principal Investigator: Dae-Kyeong Kim Inje University
Principal Investigator: Soon-Kil Kim Hanyang University
Principal Investigator: Hye-Sun Seo Soonchunhyang University Hospital
Principal Investigator: Duk-Hyun Kang Asan Medical Center
Principal Investigator: Young-Dae Kim Dong-A University Hospital
Principal Investigator: Dong-Woon Kim Chungbuk National University Hospital
Principal Investigator: Taek-Jong Hong Pusan National University Hospital
Principal Investigator: Jong-Won Ha Severance Hospital
Principal Investigator: Woo-Jung Park Hallym University Medical Center
Principal Investigator: Tae Ho Kim Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Principal Investigator: Kee-Sik Kim Daegu Catholic University Medical Center
Principal Investigator: Seung-Woo Park Sanmsung Medical Center
Principal Investigator: Wan-Joo Shim Korea University Anam Hospital
Principal Investigator: Joo-Young Yang Health Insurance Service Ilsan Hospital
Principal Investigator: Jae-Woong Choi Eulji General Hospital
Principal Investigator: Sun-Hwa Lee Chonbuk National University Hospital
Principal Investigator: Jeong-Cheon Ahn Korea University
Principal Investigator: Keun Lee Seoul Veterans Hospital
Principal Investigator: Byung-Soo Kim Daedong Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company
ClinicalTrials.gov Identifier: NCT01838850     History of Changes
Other Study ID Numbers: CS8635-SIT-11-01
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Additional relevant MeSH terms:
Layout table for MeSH terms
Olmesartan
Olmesartan Medoxomil
Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Hydrochlorothiazide
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists