search
Back to results

Efficacy of Amlodipine-Folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine

Primary Purpose

Essential Hypertension

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Amlodipine-FA tablet,low dose group
Amlodipine-FA tablet,high dose group
Amlodipine
Sponsored by
Shenzhen Ausa Pharmed Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Amlodipine, Folic Acid, Homocysteine, Blood Pressure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18-75 years;
  2. Sedentary systolic blood pressure between 140 mmHg and 180 mmHg, and/or sedentary diastolic blood pressure between 90 mmHg and 110 mmHg;
  3. Plasma homocysteine ≥ 10μmol/L;
  4. ACEI-intolerance
  5. Signed the written informed consent.

Exclusion Criteria:

  1. Pregnant women or women within lactation period;
  2. Hypersensitive to Calcium Channel Blocker (CCB) or folic acid;
  3. Easily hypersensitiveness;
  4. Diagnosed secondary hypertension or skeptical secondary hypertension;
  5. Severe hypertension (sedentary systolic blood pressure greater than or equal to 180 mmHg and/or sedentary diastolic blood pressure greater than or equal to 110 mmHg)

  6. Severe diseases:

    1. Cardiovascular system:Diagnosed cardia insufficiency (New York Health Association [NYHA] Ⅲ level and higher);Hypertrophic obstructive cardiomyopathy (HOCM);Clinical significantly Valvular Disease of the Heart (VDH);Acute coronary syndrome or coronary artery interventional therapy or coronary artery bypass graft within three months;Severe arrhythmia such as atrial flutter, atrial fibrillation, atrioventricular block above Ⅱlevel, et al;
    2. Alimentary system:Active virus hepatitis;Any of alanine aminotransferase (ALT), aspartate aminotransferase (AST), galactosylhydroxylysyl glucosyltransferase (GGT), alkaline phosphatase (ALP), total bilirubin (TBIL), Direct Bilirubin (DB) was above 2 times of it's normal value upper limit, albumin (ALB) greater than 30 g/L;Stomach bulk resect and gastrojejunostomy;Stomach intestine malabsorption;
    3. Urinary system:Serum creatinine greater than or equal to 200 mmol/L;Diagnosed stenosis of renal artery, solitary kidney;Renal transplantation;
    4. Endocrine system:Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (fasting glucose greater than or equal to 11.1 mmol/L);Diagnosed and uncontrolled hyperthyrosis;
    5. Respiratory system:Pulmonary Heart Disease;Chronic Obstructive Pulmonary Disease(COPD);
    6. Neuropsychiatric system:Transient Ischemia Attach (TIA) or stroke within 3 months;Severe peripheral nerve or vegetative nerve functional disturbance; Psyche or nervous system dysfunction;Drugs or alcohol dependence;
    7. Others:Malignant tumor, malnutrition, haematogenesis dysfunction, et al;
  7. Obviously abnormal laboratory examination or signs;
  8. Taking other antihypertensive drugs and unwilling to stop;
  9. Taking folic acid or other Vitamin B groups and unwilling to stop;

  10. Ever to participant in any drug trial not yet approved within 4 weeks before the first visit.

    -

Sites / Locations

  • The Affiliated Hospital of Xuzhou Medical College
  • The Second Affiliated Hospital of Nanchang UniversityRecruiting
  • Ruijin Hospital, Shanghai Jiao Tong UnivesityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Amlodipine

Amlodipine-FA tablet,low dose group

Amlodipine-FA tablet,high dose group

Arm Description

5mg amlodipine,once daily for 8 weeks

5mg amlodipine combined with 0.4mg of folic acid (FA),once daily for 8 weeks.

5mg amlodipine combined with 0.8mg of folic acid (FA),once daily for 8 weeks.

Outcomes

Primary Outcome Measures

Combined effective rate of blood pressure and plasma homocysteine reduction

Secondary Outcome Measures

Blood pressure reduction or plasma homocysteine reduction

Full Information

First Posted
September 30, 2013
Last Updated
September 30, 2013
Sponsor
Shenzhen Ausa Pharmed Co.,Ltd
Collaborators
Ruijin Hospital, Second Affiliated Hospital of Nanchang University, Xuzhou Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT01956786
Brief Title
Efficacy of Amlodipine-Folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine
Official Title
Efficacy of Amlodipine-Folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine in Patients With Mild to Moderate Hypertension, Hyperhomocysteinemia and Angiotension-Converting Enzyme Inhibitor Intolerance
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Ausa Pharmed Co.,Ltd
Collaborators
Ruijin Hospital, Second Affiliated Hospital of Nanchang University, Xuzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the efficacy of Amlodipine-Folic Acid Tablets on reduction of blood pressure and plasma total homocysteine.
Detailed Description
Traditional risk factors are estimated to account for only part of cardiovascular disease (CVD)risk. Non-traditional risk factors such as increased homocysteine concentrations are believed to be causally related to CVD. The interactive effect between hypertension and hyperhomocysteinemia on the risk of CVD has received great attention. Methylenetetrahydrofolate reductase (MTHFR)was the main regulatory enzymes for homocysteine metabolism. MTHFR converts 5,10-methylene-THF into 5-methyl-THF. Polymorphism of MTHFR C677T leads to a reduction in enzyme activity, which may lead to an increased concentration of plasma homocysteine and lower levels of serum folate, particularly in those with low folate intake. Enalapril Maleate-Folate Tablets, known to reduce both blood pressure and serum homocysteine and thereby preventing stroke, was found to have adverse events, such as cough, called ACEI-intolerance in some patients. In the present study, we sought to assess:(1)the efficacy and safety of Amlodipine-Folic Acid Tablets in lowing blood pressure and homocysteine in patients with mild to moderate hypertension, hyperhomocysteinemia (hcy≥10μmol/L)and ACEI intolerance;(2)whether the blood pressure and homocysteine-lowing efficacy of Amlodipine-Folic Acid Tablets can be modified by individual MTHFR C677T polymorphisms. In all, about 540 patients with mild to moderate hypertension, hyperhomocysteinemia and ACEI intolerance will be enrolled in this trial. Eligible subjects are randomly and double-blindly assigned to one of the three treatment groups:1)amlodipine tablet(5mg,control group);2)amlodipine-folic acid tablet(5mg amlodipine combined with 0.4mg of folic acid,low FA group);or 3)amlodipine-folic acid tablet (5mg amlodipine combined with 0.8mg of folic acid,high FA group),once daily for 8 weeks. The allocation of participants was programmed by an independent statistical coordinating center,encrypted,and sent to each study center.Tablet containers were labeled only with the name of the trial and the allocated concealment number.The participants,care partners,and all staff directly involved in the trial were blinded to interventions during the period of the trial. Demographic and clinical information were obtained at baseline. Blood pressure was examined at baseline and every two weeks for a total period of 8 weeks. Blood homocysteine and folate concentrations were examined at baseline and at 4th、8th weeks of the trial. MTHFR C677T genotypes were determined for each study subject. All analyses will be performed according to the principle of intention to treat.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Amlodipine, Folic Acid, Homocysteine, Blood Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amlodipine
Arm Type
Active Comparator
Arm Description
5mg amlodipine,once daily for 8 weeks
Arm Title
Amlodipine-FA tablet,low dose group
Arm Type
Experimental
Arm Description
5mg amlodipine combined with 0.4mg of folic acid (FA),once daily for 8 weeks.
Arm Title
Amlodipine-FA tablet,high dose group
Arm Type
Experimental
Arm Description
5mg amlodipine combined with 0.8mg of folic acid (FA),once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Amlodipine-FA tablet,low dose group
Other Intervention Name(s)
low dose
Intervention Description
5mg amlodipine combined with 0.4mg folic acid,once daily (Low-dose group)
Intervention Type
Drug
Intervention Name(s)
Amlodipine-FA tablet,high dose group
Other Intervention Name(s)
high dose
Intervention Description
5mg amlodipine combined with 0.8mg folic acid,once daily (High-dose group)
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Other Intervention Name(s)
control
Intervention Description
5mg amlodipine,once daily
Primary Outcome Measure Information:
Title
Combined effective rate of blood pressure and plasma homocysteine reduction
Time Frame
Blood pressure was examined at baseline and every 2 weeks for a total period of 8 weeks.Blood homocysteine concentrations were measured at baseline and at 4th and 8th week of the trial.
Secondary Outcome Measure Information:
Title
Blood pressure reduction or plasma homocysteine reduction
Time Frame
Blood pressure was examined at baseline and every 2 weeks of a total period of 8 weeks. Blood homocysteine concentrations was examined at baseline and at 4th and 8th week of the trial.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-75 years; Sedentary systolic blood pressure between 140 mmHg and 180 mmHg, and/or sedentary diastolic blood pressure between 90 mmHg and 110 mmHg; Plasma homocysteine ≥ 10μmol/L; ACEI-intolerance Signed the written informed consent. Exclusion Criteria: Pregnant women or women within lactation period; Hypersensitive to Calcium Channel Blocker (CCB) or folic acid; Easily hypersensitiveness; Diagnosed secondary hypertension or skeptical secondary hypertension; Severe hypertension (sedentary systolic blood pressure greater than or equal to 180 mmHg and/or sedentary diastolic blood pressure greater than or equal to 110 mmHg) Severe diseases: Cardiovascular system:Diagnosed cardia insufficiency (New York Health Association [NYHA] Ⅲ level and higher);Hypertrophic obstructive cardiomyopathy (HOCM);Clinical significantly Valvular Disease of the Heart (VDH);Acute coronary syndrome or coronary artery interventional therapy or coronary artery bypass graft within three months;Severe arrhythmia such as atrial flutter, atrial fibrillation, atrioventricular block above Ⅱlevel, et al; Alimentary system:Active virus hepatitis;Any of alanine aminotransferase (ALT), aspartate aminotransferase (AST), galactosylhydroxylysyl glucosyltransferase (GGT), alkaline phosphatase (ALP), total bilirubin (TBIL), Direct Bilirubin (DB) was above 2 times of it's normal value upper limit, albumin (ALB) greater than 30 g/L;Stomach bulk resect and gastrojejunostomy;Stomach intestine malabsorption; Urinary system:Serum creatinine greater than or equal to 200 mmol/L;Diagnosed stenosis of renal artery, solitary kidney;Renal transplantation; Endocrine system:Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (fasting glucose greater than or equal to 11.1 mmol/L);Diagnosed and uncontrolled hyperthyrosis; Respiratory system:Pulmonary Heart Disease;Chronic Obstructive Pulmonary Disease(COPD); Neuropsychiatric system:Transient Ischemia Attach (TIA) or stroke within 3 months;Severe peripheral nerve or vegetative nerve functional disturbance; Psyche or nervous system dysfunction;Drugs or alcohol dependence; Others:Malignant tumor, malnutrition, haematogenesis dysfunction, et al; Obviously abnormal laboratory examination or signs; Taking other antihypertensive drugs and unwilling to stop; Taking folic acid or other Vitamin B groups and unwilling to stop; Ever to participant in any drug trial not yet approved within 4 weeks before the first visit. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Jiguang, MD
Organizational Affiliation
Ruijin Hospital, Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital of Xuzhou Medical College
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Zhirong, MD
Phone
86-0516-85802111
Email
xzzrw@163.com
First Name & Middle Initial & Last Name & Degree
Wang Zhirong, MD
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng Xiaoshu, MD
Phone
86-791-6268844
Email
xiaoshumenfan@126.com
First Name & Middle Initial & Last Name & Degree
Cheng Xiaoshu, MD
Facility Name
Ruijin Hospital, Shanghai Jiao Tong Univesity
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Jiguang, MD
Phone
86-021-64370045
Email
jiguangw@gmail.com
First Name & Middle Initial & Last Name & Degree
Wang Jiguang, MD

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Amlodipine-Folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine

We'll reach out to this number within 24 hrs