Fimasartan Achieving SBP Target (FAST) Study

NCT02495324 | Completed Phase 4

• 1 other identifier: BR-FVO-CT-401
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Fimasartan compared to Valsartan and Olmesartan(reference group) in patients with mild to moderate essential hypertension. Patients have 2 weeks of placebo run-in and wash out period, 2 weeks of taking required dose and 4 weeks of taking double dose.

Conditions

Essential,Hypertension

Outcome Measures

Primary Outcomes (1)

• Change of sitting SBP from baseline after taking investigational products for 6 weeks.

  6 weeks from baseline visit

Study Arms (3)

Fimasartan

EXPERIMENTAL

Placebo daily for 2 weeks and Fimasartan 60mg daily for 2 weeks and 120mg daily for 4 weeks

Drug: Placebo; Drug: Fimasartan

Valsartan

ACTIVE COMPARATOR

Placebo daily for 2 weeks and Valsartan 80mg daily for 2 weeks and 160mg daily for 4 weeks

Drug: Placebo; Drug: Valsartan

Olmesartan medoxomil

OTHER

Reference group. Placebo daily for 2 weeks and Olmesartan 10mg daily for 2 weeks and 20mg daily for 4 weeks

Drug: Placebo; Drug: Olmesartan medoxomil

Interventions

Placebo DRUG

2 weeks of placebo PO daily

Fimasartan; Olmesartan medoxomil; Valsartan

Fimasartan DRUG

60mg 1 tab PO daily for 2 weeks and 120mg 1 tab PO daily for 4 weeks

Also known as: Kanarb Tab

Fimasartan

Valsartan DRUG

80mg 1 tab PO daily for 2 weeks and 160mg 1 tab PO daily for 4 weeks

Also known as: Diovan Tab

Valsartan

Olmesartan medoxomil DRUG

10mg 1 tab PO daily for 2 weeks and 20mg 1 tab PO daily for 4 weeks

Also known as: Olmetec Tab

Olmesartan medoxomil

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who voluntarily signed informed consent for participating in this clinical trial
• Male and female between 19 and 70 years old
• Subjects whose mean sitting SBP(siSBP) of 3 measurements is above 140mmHg at visit 2 with mild to moderate essential hypertension (Subjects who have not taken anti-hypertensive drugs within 3 months should have mean siSBP above 140mmHg at visit 1)
• Subject who can understand the trial procedures and be willing to cooperate the trial

You may not qualify if:

• Severe hypertension patients with mean siSBP ≥ 180mmHg or siDBP ≥110mmHg at the assessment of Screening visit(Visit1) and Baseline visit (Visit2).
• Patients whose difference between maximum and minimum among 3 times of blood pressure measurement is over 20mmHg(siSBP) or 10mmHg(siDBP) at visit1 and visit2.
• Patients whose medication compliance is under 70% at visit 2.
• Secondary hypertension patients, but not limited to the following diseases (example: renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc).
• Patients who have postural hypotension with manifestation.
• Subjects with severe insulin-dependent Diabetes Mellitus(DM) or uncontrolled DM(HbA1c \> 9% at screening visit, modified dosage of an oral hypoglycemic agent within 12 weeks prior to screening visit, or currently use of active insulin treatment).
• History of malignant tumor including leukemia and lymphoma in the past 5 years.
• Subjects with chronic inflammatory disease requiring an chronic anti-inflammatory therapy, past or current medical history with wasting disease, autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus) or connective tissue disease.
• Medical history with hypersensitivity to angiotensin II antagonist.
• Clinically significant renal and liver disorders such as dialysis, cirrhosis, biliary obstruction, cholestasis and liver failure. Patients who have below abnormality in the laboratory results at screening visit.
• Creatinine clearance(Cockroft-Gault)\<30mL/min
• ALT, AST ≥ 2 times upper normal limit
• Clinically significant hypokalemia(K\<3.5mmol/L) or hyperkalemia(K\>5.5mmol/L)
• Subjects have history of any of the followings within the past 6 months or determined clinically significant by investigators.
• Severe heart disease (Heart failure New York Heart Association(NYHA) class 3 and 4), ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular disease, percutaneous transluminal coronary angioplasty or coronary artery bypass graft.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (8)

The Catholic University of Korea, Seoul St.Mary's Hospital

Seoul, Banpo-dong, Seocho-gu, 137-701, South Korea

Location

The Catholic University of Korea, Incheon St.Mary's Hospital

Incheon, Bupyeong-gu, 403-720, South Korea

Location

The Catholic University of Korea, St. Paul's Hospital

Seoul, Dongdaemun-gu, 130-709, South Korea

Location

The Catholic University of Korea, Bucheon St.Mary's Hospital

Bucheon-si, Gyeonggi-do, 420-717, South Korea

Location

The Catholic University of Korea, St.Vincent's Hospital.

Suwon, Gyeonggi-do, 442-723, South Korea

Location

The Catholic University of Korea,Uijeongbu St.Mary's Hospital

Uijeongbu-si, Gyeonggi-do, 480-717, South Korea

Location

The Catholic University of Korea, Daejeon St. Mary's Hospital

Daejeon, Jung-gu/Daeheung-ro, 301-723, South Korea

Location

The Catholic University of Korea,Yeouido St.Mary's Hospital

Seoul, Yeongdeungpo-gu, 150-713, South Korea

Location

Related Publications (1)

• Chung WB, Ihm SH, Jang SW, Her SH, Park CS, Lee JM, Chang K, Jeon DS, Yoo KD, Seung KB. Effect of Fimasartan versus Valsartan and Olmesartan on Office and Ambulatory Blood Pressure in Korean Patients with Mild-to-Moderate Essential Hypertension: A Randomized, Double-Blind, Active Control, Three-Parallel Group, Forced Titration, Multicenter, Phase IV Study (Fimasartan Achieving Systolic Blood Pressure Target (FAST) Study). Drug Des Devel Ther. 2020 Jan 23;14:347-360. doi: 10.2147/DDDT.S231293. eCollection 2020.

  PMID: 32158190 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

fimasartan; Valsartan; Olmesartan Medoxomil

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Imidazoles

Study Officials

• KI-BAE SEUNG, Ph.D

  Cardiovascular center, Seoul St.Mary's Hospital, The Catholic University of Korea

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 13, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 5, 2017

Record last verified: 2017-07

Locations

KR (8)