- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01848873
Efficacy of Amlodipine-folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine
Efficacy of Amlodipine-folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine in Patients With Mild to Moderate Hypertension and Hyperhomocysteinemia :a Double-blind Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 concentration 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. In the present study, we sought to assess: (1) the efficacy and safety of Amlodipine-folic Acid Tablets in lowering blood pressure and homocystein in patients with mild to moderate hypertension and hyperhomocysteinemia (hcy≥10μmol/L);(2) if the blood pressure and homocysteine-lowering efficacy of Amlodipine-folic Acid Tablets can be modified by individual methylenetetrahydrofolate reductase (MTHFR) C677T polymorphisms.
In all, about 756 patients with mild or moderate hypertension and hyperhomocysteinemia will be recruited from about 18 hospitals in different Chinese regions. All hospitals are certified as clinical pharmacology centers by the State Food and Drug Administration (SFDA) in China. Eligible subjects are randomly and double-blindly assigned to one of the three treatment groups: 1) amlodipine tablet (5 mg, control group); 2) amlodipine-folic acid tablet (5mg amlodipine combined with 0.4 mg of folic acid, low FA group); or 3) amlodipine-folic acid tablet (5 mg amlodipine combined with 0.8 mg 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 4 and 8 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Yong Huo, MD
- Phone Number: 86-10-66551122-2704
- Email: huoyong18@126.com
Study Contact Backup
- Name: Yan Zhang, MD
- Phone Number: 86-10-66530556
- Email: drzhy1108@163.com
Study Locations
-
-
Anhui
-
Hefei, Anhui, China, 230022
- Not yet recruiting
- The First Affiliated Hospital of Anhui Medical University
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
-
Beijing, Beijing, China, 100029
- Recruiting
- Anzhen Hospital,Capital Medical University
-
Beijing, Beijing, China, 100036
- Recruiting
- Peking University First Hospital
-
-
Fujian
-
Fuzhou, Fujian, China, 350005
- Not yet recruiting
- First Affiliated Hospital of Fujian Medical University
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510030
- Not yet recruiting
- Guangdong General Hospital
-
-
Heilongjiang
-
Haibin, Heilongjiang, China, 150001
- Not yet recruiting
- First Affiliated Hospital of Harbin Medical University
-
-
Hubei
-
Wuhan, Hubei, China, 430022
- Not yet recruiting
- Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
-
-
Jiangsu
-
Xuzhou, Jiangsu, China, 221006
- Recruiting
- The Affiliated Hospital of Xuzhou Medical College
-
-
Jiangxi
-
Nanchang, Jiangxi, China, 330006
- Not yet recruiting
- The Second Affiliated Hospital of Nanchang University
-
-
Liaoning
-
Shenyang, Liaoning, China, 110002
- Not yet recruiting
- First Affiliated Hospital of China Medical University
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Not yet recruiting
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
-
Shanghai, Shanghai, China, 200032
- Not yet recruiting
- Zhongshan Hospital Fudan University
-
-
Shanxi
-
Xi'an, Shanxi, China, 710061
- Not yet recruiting
- First Affiliated Hospital of the School of Medicine, Xi'an Jiaotong University
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Not yet recruiting
- West China School of Medicine, West China Hospital ,Sichuan University
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- Not yet recruiting
- Second Affiliated Hospital, School of Medicine, Zhejiang University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18-75 years;
- Seated systolic blood pressure (SBP) between 140 mmHg and 180 mmHg and/or seated diastolic blood pressure between 90 mmHg and 110 mmHg;
- Plasma homocysteine ≥10umol/L;
- 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 secondum hypertension or skeptical secondum hypertension;
- Severe hypertension (sedentary systolic blood pressure≥180mmHg and/or sedentary diastolic blood pressure≥110mmHg)
Severe diseases:
- Cardiovascular system:
- Diagnosed cardia insufficiency (NYHAⅢ 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 Ⅱ level, 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) ≤30g/L;Stomach bulk resect and gastrojejunostomy, stomach intestine malabsorption;
- Urinary system:
- Serum creatinine≥200μmol/L ; Diagnosed stenosis of renal artery, solitary kidney, renal transplantation;
- Endocrine system:
- Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (fasting glucose≥11.1mmol/L); Diagnosed and uncontrolled hyperthyrosis;
- Respiratory system:
- Pulmonary heart disease , chronic obstructive lung disease;
- Nervous or psyche system:
- Transient ischemia attach (TIA) or stoke 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;
- Obvious signs or abnormal laboratory examination;
- Taking other antihypertensive drugs and unwilling to stop;
- Taking folic acid or other Vitamin B groups unwilling to stop.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: amlodipine-FA tablet, low dose group
5mg amlodipine combined with 0.4 mg of folic acid (FA),once daily for 8 weeks.
|
5mg amlodipine combined with 0.4 mg of folic acid, daily.
Other Names:
|
Experimental: amlodipine-FA tablet ,high dose group
5mg amlodipine combined with 0.8 mg of folic acid (FA), once daily for 8 weeks.
|
amlodipine 5mg and folic acid 0.8mg daily
Other Names:
|
Active Comparator: amolodipine
5 mg amlodipine, once daily for 8 weeks.
|
amlodipine 5mg daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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 4 and 8 weeks of the trial.
|
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 4 and 8 weeks of the trial.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure reduction or plasma homocysteine reduction
Time Frame: Blood pressure was examined at baseline and every two weeks for a total period of 8 weeks. Blood homocysteine concentrations was examined at baseline and at 4 and 8 weeks of the trial.
|
Blood pressure was examined at baseline and every two weeks for a total period of 8 weeks. Blood homocysteine concentrations was examined at baseline and at 4 and 8 weeks of the trial.
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
24-hour ambulatory blood pressure
Time Frame: 24-hour ambulatory blood pressure were examined at baseline and at 8 weeks of the trial in 96 participants.
|
24-hour ambulatory blood pressure were examined at baseline and at 8 weeks of the trial in 96 participants.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yong Huo, MD, Peking University First Hospital, Beijing, CHINA
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Nutrition Disorders
- Genetic Diseases, Inborn
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Metabolism, Inborn Errors
- Malabsorption Syndromes
- Amino Acid Metabolism, Inborn Errors
- Vitamin B Deficiency
- Hypertension
- Essential Hypertension
- Hyperhomocysteinemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Amlodipine
Other Study ID Numbers
- AUSA-amlodipine
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Essential Hypertension
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Addpharma Inc.Recruiting
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
BayerCompletedHypertension, EssentialGermany
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
Addpharma Inc.Not yet recruitingHypertension,Essential
-
Instituto de Cardiologia do Rio Grande do SulRecruitingHypertension | Hypertension,EssentialBrazil
-
Federal University of Health Science of Porto AlegreIrmandade Santa Casa de Misericórdia de Porto Alegre; Leonhardt Ventures LLCNot yet recruitingHypertension | Hypertension,Essential
Clinical Trials on amlodipine-FA tablet, low dose group
-
Shenzhen Ausa Pharmed Co.,LtdRuijin Hospital; Xuzhou Medical University; Second Affiliated Hospital of Nanchang...UnknownEssential HypertensionChina
-
Newish Technology (Beijing) Co., Ltd.Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruitingHepatocellular CarcinomaChina
-
Tasly Pharmaceutical Group Co., LtdNot yet recruiting
-
Advenchen Pharmaceuticals, LLC.RecruitingSmall Cell Lung CancerUnited States
-
Tasly Pharmaceutical Group Co., LtdCompleted
-
Bristol-Myers SquibbWithdrawn
-
Shineway Pharmaceutical Co.,LtdUnknown
-
GeneScience Pharmaceuticals Co., Ltd.The First Affiliated Hospital with Nanjing Medical University; Tongji Hospital and other collaboratorsUnknown
-
Anterogen Co., Ltd.TerminatedPerianal Fistula | Primary; ComplexKorea, Republic of