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RecruitingNCT06826872Updated Feb 14, 2025

Efficacy and Safety of SPC1001 in Patients With Essential Hypertension

A Phase 2 interventional study of SPC 1001 Mid2 and SPC 2002 in Hypertension, Essential, Cardiovascular Diseases and Cardiology, sponsored by Shin Poong Pharmaceutical Co. Ltd.. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-14.

Sponsored by Shin Poong Pharmaceutical Co. Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Registered 7 months after the study started (first participant enrolled Jun 2024, registered Feb 2025).
  • Started Jun 2024; still recruiting 2 years 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
252
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study summary

  • Objective: This study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (SPC1001) of candesartan, amlodipine, and indapamide in adult patients with essential hypertension compared to dual-component therapies of each ingredient for 8 weeks. Additionally, it seeks to confirm the contribution of each component at low doses.
  • Inclusion Criteria: Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.
  • Exclusion Criteria: Patients whose blood pressure measured at the screening and randomization visits meets the criteria of MSSBP ≥180 mmHg or MSDBP ≥110 mmHg, among other conditions.
  • Methods: This study is a multicenter, randomized, double-blind, parallel-group, phase 2b clinical trial to evaluate the safety and efficacy of the investigational drug after 8 weeks of administration.

Screening assessments will be conducted within 4 weeks prior to randomization, and patients who meet the inclusion and exclusion criteria at the screening visit will be enrolled in the study after providing informed consent. These participants will undergo a 2-week run-in period during which they will take a placebo and participate in a lifestyle modification program.

02

Conditions studied

  • Hypertension, Essential
  • Cardiovascular Diseases
  • Cardiology

Keywords

  • blood pressure
  • Low-dose combination therapy
  • candesartan
  • amlodipine
  • indapamide
03

In context

Essential Hypertension

478 studies on the registry are indexed under Essential Hypertension; 74 are open to participants now.

This study's planned enrollment of 252 is above the median of 144 across 406 interventional studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

Shin Poong Pharmaceutical Co. Ltd. is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Browse Shin Poong Pharmaceutical Co. Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.

Exclusion criteria

Exclusion Criteria:

  • Patients whose blood pressure measured at the screening and randomization visits meets the criteria of MSSBP ≥180 mmHg or MSDBP ≥110 mmHg, among other conditions.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
252 participants (estimated)

Study arms

  • Active comparator
    SPC 1001 Mid2

    Drug: SPC 1001 Mid2

  • Active comparator
    SPC2002

    Drug: SPC 1001 Mid2 · Drug: SPC 2002

  • Active comparator
    SPC2003

    Drug: SPC 1001 Mid2 · Drug: SPC 2003

  • Active comparator
    SPC2004

    Drug: SPC 1001 Mid2 · Drug: SPC 2004

Interventions

  • DrugSPC 1001 Mid2

    low-dose combination therapy

  • DrugSPC 2002

    low-dose combination therapy

  • DrugSPC 2003

    low-dose combination therapy

  • DrugSPC 2004

    low-dose combination therapy

06

What researchers measure

Primary outcomes

  1. The primary endpoint was determined by evaluating how mean sitting systolic blood pressure varied between the baseline measurement and week 8.

    Time frame: Change from Baseline in MSSBP at Week 8

07

Study locations

1 of 1 sites recruiting
  • CHA Gangnam Medical Center, CHA University, Seoul, Republic of Korea
    Seoul, 06135, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — It is planned to be publicly available in the form of a future journal submission.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06826872
Lead sponsor
Shin Poong Pharmaceutical Co. Ltd.
Responsible party
Sponsor
First posted
Feb 14, 2025
Start date
Jun 12, 2024
Primary completion
Oct 8, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Feb 14, 2025

Study contacts

YeongJin Jeong, Master
Contact
yjjeong@shinpoong.co.kr
+82 2-2189-3944

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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