RecruitingPhase 2NCT06826872

Efficacy and Safety of SPC1001 in Patients With Essential Hypertension

A Multicenter, Randomized, Double-Blind, Parallel, Phase 2(2b) Clinical Trial to Compare and Evaluate the Efficacy and Safety of SPC1001 in Patients With Essential Hypertension


Sponsor

Shin Poong Pharmaceutical Co. Ltd.

Enrollment

252 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing SPC1001, a new investigational drug, for the treatment of essential hypertension — high blood pressure with no single identifiable cause, which is the most common type of high blood pressure. **You may be eligible if...** - You are 18 or older - You have been diagnosed with essential (primary) hypertension - Your blood pressure is not adequately controlled on your current medications, OR you are not yet on medication - You are not pregnant and are willing to use contraception if applicable **You may NOT be eligible if...** - Your high blood pressure is caused by another condition (such as kidney disease or a hormone tumor) - You have had a recent heart attack or stroke (within 6 months) - You have serious kidney or liver disease - You are pregnant or breastfeeding - You have been treated with SPC1001 or a similar drug previously Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

CHA Gangnam Medical Center, CHA University, Seoul, Republic of Korea

Seoul, South Korea

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NCT06826872


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