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| ID | Type | Description | Link |
|---|---|---|---|
| 201707074MIPC | Other Identifier | NTUH-REC |
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| Name | Class |
|---|---|
| National Taiwan University Hospital | OTHER |
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To assess the ability of KEFPEP® to reduce blood pressure
Primary objective-
• To assess the ability of KEFPEP® to reduce blood pressure.
Secondary objective-
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KEFPEP® | Experimental |
|
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KEFPEP® | Dietary Supplement | Twice daily (one pack before breakfast and the other before dinner) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of 5 mmHg SBP | I. Reduction of 5 mmHg from Baseline in office SBP. II. Reduction of 5 mmHg from Baseline in 24-hour ambulatory SBP. | At week 12 |
| Reduction of 10 mmHg SBP | I. Reduction of 10 mmHg from Baseline in office SBP. II. Reduction of 10 mmHg from Baseline in 24-hour ambulatory SBP. | At week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Office SBP and diastolic blood pressure (DBP) | Compare the change from Baseline in office SBP and DBP | Baseline (Day 1/Visit 3), Week 4 (Visit 4), Week 8 (Visit 5), and Week 12 (Visit 6) |
| 24-hour ambulatory |
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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:
Body weight≤90 kg, and BMI≥18.5 kg/m2 or < 30 kg/m2.
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:
Patients with clinically significant abnormalities in the following laboratory parameters within 2 weeks prior to Screening visit or during the screening period:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Jen-Kuang Lee, MD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14656957 | Background | Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003 Dec;42(6):1206-52. doi: 10.1161/01.HYP.0000107251.49515.c2. Epub 2003 Dec 1. | |
| 16305721 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jul 12, 2017 | Apr 18, 2024 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo |
| Other |
Twice daily (one pack before breakfast and the other before dinner) |
|
Compare the change from Baseline in 24-hour ambulatory SBP and 24-hour ambulatory DBP
| Baseline (Day 1/Visit 3) and Week 12 (Visit 6) |
| Biomarkers of blood vessel inflammation | Biomarker: high sensitivity C-Reactive Protein (hsCRP); Unit of Measure: mg/L (milligrams per liter). By separating these biomarkers into distinct outcome measures, it ensures clarity in reporting and analysis, especially when different units of measure are involved. | Baseline (Day 1/Visit 3) and Week 12 (Visit 6) |
| Biomarkers of blood vessel damage | Biomarker: creatine kinase; Unit of Measure: U/L (unit per liter). By separating these biomarkers into distinct outcome measures, it ensures clarity in reporting and analysis, especially when different units of measure are involved. | Baseline (Day 1/Visit 3) and Week 12 (Visit 6) |
| Follow-up and safety analyses -Vital signs | Measure the subject's body temperature (°C), respiratory rate per minute, and heartbeat/pulse per minute. (Measured the subject's sitting office blood pressure at revisit. At each measurement, the subject should rest in an air-conditioned space for approximately 30 minutes until the blood pressure stabilizes before using an electronic sphygmomanometer to measure the blood pressure while seated. The subject's body temperature (°C), respiratory rate per minute, and heartbeat/pulse per minute were displayed simultaneously in the electronic blood pressure monitor.) | The 2-week follow-up period once completing the 12-week dietary |
| Follow-up and safety analyses -Adverse events (AEs) | Adverse events were according to MedDRA version 26.0, and all events were classified according to Preferred Terms (PT) and System Organ Class (SOC). | The 2-week follow-up period once completing the 12-week dietary |
| Background |
| Cholongitas E, Papatheodoridis GV, Vangeli M, Terreni N, Patch D, Burroughs AK. Systematic review: The model for end-stage liver disease--should it replace Child-Pugh's classification for assessing prognosis in cirrhosis? Aliment Pharmacol Ther. 2005 Dec;22(11-12):1079-89. doi: 10.1111/j.1365-2036.2005.02691.x. |
| 32208570 | Background | Chronic kidney disease in adults: assessment and management. London: National Institute for Health and Care Excellence (NICE); 2015 Jan. Available from http://www.ncbi.nlm.nih.gov/books/NBK555204/ |