NCT01816698

Brief Summary

Prehypertension are associated with an increased risk of atherosclerosis and coronary artery disease, and often complicated with the metabolic disorder of glucose and lipid. The comprehensive prevention of hypertension is still an important and complex clinical issue. Taurine is one of the ingredients of Chinese medicine bezoar ,as an endogenous amino acids is central inhibitory neurotransmitter, can regulate the excitability of nerve tissue, regulate body temperature, therefore, antipyretic, sedative, analgesic, anti-inflammatory,the role of anti-rheumatic, anti-convulsant. In addition, Taurine inhibits platelet aggregation in the circulatory system, lower blood lipids, to maintain the body's normal blood pressure and prevent atherosclerosis; protective effect on myocardial cells, can be anti-arrhythmic; special efficacy to lower blood cholesterol, to treat heart failure. The effect of oral Taurine on blood pressure is not consistent, however, many animal study has shown that oral administration of Taurine, could reduce 24-hour mean arterial systolic and diastolic blood pressure in spontaneous hypertensive rats. Furthermore, Taurine interfere with calcium and low affinity binding of the calcium binding sites, decrease the voltage-dependent Ca2+channel in vascular smooth muscle relaxation, vasodilation, lower blood pressure.In a prospective, double-blind, randomized, and parallel-group study, we will evaluate the effects of Taurine granule on blood pressure and metabolic parameters in prehypertensive and mild hypertensive patients. This study will help develop future comprehensive prevention and treatment strategies for hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

November 24, 2015

Status Verified

November 1, 2015

Enrollment Period

2.2 years

First QC Date

March 20, 2013

Last Update Submit

November 23, 2015

Conditions

Prehypertension

Keywords

HypertensionTaurineMetabolism

Outcome Measures

Primary Outcomes (1)

  • The decrease in blood pressure after an 12-week oral Taurine granule administration.

    Evaluate the effects of Taurine granule on blood pressure and metabolic parameters in prehypertensive patients after an 12-week oral administration.

    12 weeks

Study Arms (2)

Taurine

ACTIVE COMPARATOR

Interventions Drug: Taurine granule Arms: Group 1

Drug: Taurine granule

Placebo

PLACEBO COMPARATOR

Interventions Drug: Placebo Arms: Group 2

Drug: Placebo

Interventions

Taurine granuleDRUG

1 package(1.6g taurine granule) once a day after meals, 12 weeks

Also known as: Taurine granule, H20003861.
Taurine
PlaceboDRUG

Placebo: 1 package once a day after meals, 12 weeks

Also known as: Placebo packaged similar to Taurine granule
Placebo

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Blood pressure: 120mmHg≤SBP\<140mmHg.

You may not qualify if:

  • Diabetes
  • Hypertension: SBP≥140mmHg, or DBP≥90mmHg.
  • known allergy to trial drugs
  • Myocardial infarction or cerebrovascular accident in the year preceding the trial
  • Clinical Congestive Heart Failure
  • Secondary hypertension
  • Pregnancy or lactating women
  • Malignant tumor
  • Gastroesophageal reflux or gastroduodenal ulcer
  • History of hepatitis or cirrhosis
  • History of kidney disease
  • Body weight﹤35Kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

PrehypertensionHypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Scientist of the National Key Basic Research and Development Program (973 Program)

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 22, 2013

Study Start

December 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

November 24, 2015

Record last verified: 2015-11

Locations

CN(1)