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Clinical Trials/NCT06393621
NCT06393621CompletedNot Applicable

Prospective, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Investigate the Effectiveness of KEFPEP® on Regulating High Blood Pressure

National Chung Hsing University1 site in 1 country46 target enrollmentStarted: July 26, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
46
Locations
1
Primary Endpoint
Reduction of 5 mmHg SBP
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To assess the ability of KEFPEP® to reduce blood pressure

Detailed Description

Primary objective-

• To assess the ability of KEFPEP® to reduce blood pressure.

Secondary objective-

  1. To access the effect of KEFPEP® on vascular inflammation or damage.
  2. To access the effect of KEFPEP® on cardiovascular diseases prevention.
  3. To assess the safety of KEFPEP® .

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Male or female patient ages 20 years or older.
  • •Belong to either one of the following categories based on the Seventh Report of the Joint National Committee (JNC 7) as measured by office BP at Screening visit:
  • •Prehypertension (SBP 120 - 139 mmHg or DBP 80 - 89 mmHg)
  • •Stage I hypertension (SBP 140 - 159 mmHg or DBP 90 - 99 mmHg)
  • •Body weight≤90 kg, and BMI≥18.5 kg/m2 or < 30 kg/m
  • •NOT on any antihypertensive treatment at the time of entry into the study.
  • •Willing to comply with the study procedures and follow-ups.
  • •Understand the nature of the study, and have signed informed consent forms.

Exclusion Criteria

  • •Patients with any of the following conditions within 6 months prior to study participation:
  • •Secondary hypertension
  • •Uncontrolled diabetes mellitus
  • •Renal disease based on the investigator's judgment
  • •Severe hepatic disease with Child-Pugh class C
  • •Severe anaemia
  • •Any malignant disease or serious disease
  • •Patients with clinically significant abnormalities in the following laboratory parameters within 2 weeks prior to Screening visit or during the screening period:
  • •HbA1c > 9%
  • •AST or ALT ≥ 3 x upper limit of normal (ULN)
  • •Estimated glomerular filtration rate (eGFR) < 50 ml/min/1.73 m2
  • •Serum creatinine ≥ 3 x ULN
  • •Hemoglobin < 10 g/dL
  • •History of milk allergy and/or lactose intolerance.
  • •History of alcohol abuse.
  • •Constant use of oral medication or supplements affecting blood pressure.
  • •Female patients who are pregnant, planning to become pregnant, or lactating.
  • •Male or female patients of child-bearing potential do not agree to use an effective method of contraception during the study period.
  • •Currently participating in any other interventional clinical study within 30 days
  • •Patients who are considered not suitable for the study according to the investigator's judgment for the patient's best interest.

Outcomes

Primary Outcomes

Reduction of 5 mmHg SBP

Time Frame: At week 12

I. Reduction of 5 mmHg from Baseline in office SBP. II. Reduction of 5 mmHg from Baseline in 24-hour ambulatory SBP.

Reduction of 10 mmHg SBP

Time Frame: At week 12

I. Reduction of 10 mmHg from Baseline in office SBP. II. Reduction of 10 mmHg from Baseline in 24-hour ambulatory SBP.

Secondary Outcomes

  • Biomarkers of blood vessel damage(Baseline (Day 1/Visit 3) and Week 12 (Visit 6))
  • Follow-up and safety analyses -Adverse events (AEs)(The 2-week follow-up period once completing the 12-week dietary)
  • Office SBP and diastolic blood pressure (DBP)(Baseline (Day 1/Visit 3), Week 4 (Visit 4), Week 8 (Visit 5), and Week 12 (Visit 6))
  • 24-hour ambulatory(Baseline (Day 1/Visit 3) and Week 12 (Visit 6))
  • Biomarkers of blood vessel inflammation(Baseline (Day 1/Visit 3) and Week 12 (Visit 6))
  • Follow-up and safety analyses -Vital signs(The 2-week follow-up period once completing the 12-week dietary)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chuan -Mu Chen

Chair Professor

National Chung Hsing University

Study Sites (1)

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Investigate the Effectiveness of KEFPEP®... | Clinical Trial