deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT01135212

The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension

A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension (Phase IIIb)

Sponsor: Boryung Pharmaceutical Co., Ltd

Conditions Hypertension
Updated 9 times since 2017 Last updated: Aug 22, 2012 Started: Apr 30, 2010 Primary completion: Apr 30, 2011 Completion: May 31, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Hypertension and is currently completed. Boryung Pharmaceutical Co., Ltd leads this study, which shows 9 recorded versions since 2010 — indicating limited longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.

Study Description(click to expand)

A randomized, double-blind, Candesartan controlled, parallel group comparison clinical study to evaluate the antihypertensive efficacy and safety of Fimasartan in patients with mild to moderate hypertension Approximately 288 patients will be enrolled in 10 centers in South Korea. This study has planned 5 visits during 14 weeks (placebo run-in period 2 weeks, treatment period 12 weeks). All of the subjects who agreed to participate in this study and gave the written informed consent voluntary are assessed the exclusion and inclusion criteria and receive the investigational product(placebo) at screening visit. During more than 14 days of placebo run-in period, subjects have to stop the previous anti-hypertension drug. After 2 weeks, subjects are assessed the final eligibility and randomized into one of 3 groups(Fimasartan 60mg, Fimasartan 120mg, Candesartan 8mg) at baseline visit. Subjects take physical and laboratory tests and receive the investigational products per 4weeks during treatment period (12weeks).

A randomized, double-blind, Candesartan controlled, parallel group comparison clinical study to evaluate the antihypertensive efficacy and safety of Fimasartan in patients with mild to moderate hypertension Approximately 288 patients will be enrolled in 10 centers in South Korea. This study has planned 5 visits during 14 weeks (placebo run-in period 2 weeks, treatment period 12 weeks). All of the subjects who agreed to participate in this study and gave the written informed consent voluntary are assessed the exclusion and inclusion criteria and receive the investigational product(placebo) at screening visit.

During more than 14 days of placebo run-in period, subjects have to stop the previous anti-hypertension drug. After 2 weeks, subjects are assessed the final eligibility and randomized into one of 3 groups(Fimasartan 60mg, Fimasartan 120mg, Candesartan 8mg) at baseline visit. Subjects take physical and laboratory tests and receive the investigational products per 4weeks during treatment period (12weeks).

Status Flow

~Jan 2017 – ~Jun 2017 · 5 months · monthly snapshotCompleted~Jun 2017 – ~Jun 2018 · 12 months · monthly snapshotCompleted~Jun 2018 – ~Feb 2020 · 20 months · monthly snapshotCompleted~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Present [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

Show 4 earlier versions
  1. Feb 2020 — Jan 2021 [monthly]

    Completed PHASE3

  2. Jun 2018 — Feb 2020 [monthly]

    Completed PHASE3

  3. Jun 2017 — Jun 2018 [monthly]

    Completed PHASE3

  4. Jan 2017 — Jun 2017 [monthly]

    Completed PHASE3

    First recorded

Apr 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Boryung Pharmaceutical Co., Ltd
  • Daegu Catholic University Medical Center
  • Dong-A medical center
  • Gyeongsang National University Hospital
  • Inje University
  • Keimyung University
  • Kosin University Gospel Hospital
  • Kyungpook National University Hospital
  • Pusan National University Hospital
  • Pusan National University Yangsan Hospital
  • Ulsan University Hospital
  • Yeungnam University Hospital
Data source: Boryung Pharmaceutical Co., Ltd

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations