Fimasartan in the Senior Subjects

NCT ID: NCT03246555

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-15
• Study Completion Date: 2019-12-09

Brief Summary

The objective of this study is to confirm the noninferiority of the blood pressure lowering effect of fimasartan and evaluate its safety compared to perindopril in the elderly with essential hypertension.

Conditions

The Elderly (≥ 70 Years) With Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Fimasartan or Fimasartan/Hydrochlorothiazide

Group Type: EXPERIMENTAL

Fimasartan or Fimasartan/Hydrochlorothiazide

Intervention Type: DRUG

The treatment in this clinical study starts with fimasartan 30 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.

Perindopril or Perindopril/Indapamide

Group Type: ACTIVE_COMPARATOR

Perindopril or Perindopril/Indapamide

Intervention Type: DRUG

The treatment in this clinical study starts with penrindopril 2.5 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.

Interventions

Fimasartan or Fimasartan/Hydrochlorothiazide

The treatment in this clinical study starts with fimasartan 30 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.

Intervention Type: DRUG

Perindopril or Perindopril/Indapamide

The treatment in this clinical study starts with penrindopril 2.5 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntarily provided a written consent to participate in this clinical study after receiving an explanation of this study

2. Elderly aged 70 years or older

3. At the screening visit (Visit 1), Blood pressure: Mean blood pressure measured 3 times on the selected arm is as below.

• For treatment-naïve patients who have not taken drugs for hypertension within the last 3 months from the screening visit: Mean siSBP ≥ 140mmHg
• For patients with essential hypertension who are taking drugs for hypertension: Mean siSBP ≥ 130mmHg

4. At the baseline visit (Visit 2), Blood pressure: Patients with mild to moderate essential hypertension whose mean siSBP measured 3 times on the selected arm is ≥140 mmHg Patients with treatment compliance of ≥70% during the placebo run-in period

5. Capable of understanding written instructions, cooperative, able to participate until the end of the clinical study

Exclusion Criteria

1. Severe hypertension patients with mean siSBP ≥ 180 mmHg or siDBP ≥ 110 mmHg (office BP) at the screening visit (Visit 1) and the baseline visit (Visit 2) (However, at screening, it is based on the blood pressures measured from both arms, and the patient is excluded if the result from any of the arms falls within the criteria.)

2. Patients with siSBP ≥ 20 mmHg and siDBP ≥ 10 mmHg in the difference between blood pressures in the selected arm at the screening visit (Visit 1)

3. Patients with a history of secondary hypertension and any history suspected of secondary hypertension (but not limited to the following: coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc.)

4. Orthostatic hypotension with symptoms

5. Patients with insulin-dependent diabetes mellitus or uncontrolled diabetes mellitus (HbA1c > 9.0% at the screening visit (Visit 1))

6. Patients with a history of malignant tumor, including leukemia and lymphoma, within the past 5 years (however, participation is allowed if it has not recurred for at least 5 years after a tumor surgery)

7. Patients with any chronic inflammatory disease requiring chronic anti-inflammatory treatment, consumption disease, autoimmune disease like rheumatoid arthritis and systemic lupus erythematosus, etc., or connective tissue disease at present or in the past

8. Patients with a history of hypersensitivity reaction to any component of the investigational product and its similar compound Renin-angiotensin system inhibitors, ACE inhibitors, thiazide diuretics and sulfonamides, Yellow 5 (Sunset Yellow FCF), etc.

9. Patients with hyperlipidemia undergoing LDL (low density lipoprotein) apheresis (patients undergoing LDL hemapheresis using a dextran sulfate cellulose)

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Bundang

Seoul, , South Korea

Countries

South Korea

References

Lee HY, Kim KI, Ihm SH, Rhee MY, Sohn IS, Park S, Jeon ES, Song JM, Pyun WB, Sung KC, Kim MH, Kim SH, Kim SY, Kim SJ, Kim EJ, Shin J, Lee SY, Chun KJ, Jeong JO, Chae SC, Yoo KD, Choi YJ, Park YH, Kim CH. A Randomized, Double-blind, Active-controlled, Two Parallel-Group, Optional Titration, Multicenter, Phase IIIb Study to Evaluate the Efficacy and Safety of Fimasartan Versus Perindopril Monotherapy With and Without a Diuretic Combination in Elderly Patients With Essential Hypertension. Clin Ther. 2021 Oct;43(10):1746-1756. doi: 10.1016/j.clinthera.2021.08.003. Epub 2021 Sep 7.

Reference Type: DERIVED

PMID: 34503866 (View on PubMed)

Kang MG, Kim KI, Ihm SH, Rhee MY, Sohn IS, Lee HY, Park S, Jeon ES, Song JM, Pyun WB, Sung KC, Kim MH, Kim SH, Kim SY, Kim SJ, Kim EJ, Shin J, Lee SY, Chun KJ, Jeong JO, Chae SC, Yoo KD, Choi YJ, Park YH, Kim CH. Fimasartan versus perindopril with and without diuretics in the treatment of elderly patients with essential hypertension (Fimasartan in the Senior Subjects (FITNESS)): study protocol for a randomized controlled trial. Trials. 2019 Jul 1;20(1):389. doi: 10.1186/s13063-019-3466-5.

Reference Type: DERIVED

PMID: 31262348 (View on PubMed)

Other Identifiers

BR-FMS-CT-304

Identifier Type: -

Identifier Source: org_study_id