Efficacy of Amlodipine-folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine
1 other identifier
interventional
756
1 country
16
Brief Summary
To evaluate the efficacy of Amlodipine-folic Acid Tablets on reduction of blood pressure and plasma homocystein.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2013
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 4, 2013
CompletedFirst Posted
Study publicly available on registry
May 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedMay 8, 2013
May 1, 2013
7 months
May 4, 2013
May 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Combined effective rate of blood pressure and plasma homocysteine reduction
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 Outcomes (1)
Blood pressure reduction or plasma homocysteine reduction
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 Outcomes (1)
24-hour ambulatory blood pressure
24-hour ambulatory blood pressure were examined at baseline and at 8 weeks of the trial in 96 participants.
Study Arms (3)
amlodipine-FA tablet, low dose group
EXPERIMENTAL5mg amlodipine combined with 0.4 mg of folic acid (FA),once daily for 8 weeks.
amlodipine-FA tablet ,high dose group
EXPERIMENTAL5mg amlodipine combined with 0.8 mg of folic acid (FA), once daily for 8 weeks.
amolodipine
ACTIVE COMPARATOR5 mg amlodipine, once daily for 8 weeks.
Interventions
5mg amlodipine combined with 0.4 mg of folic acid, daily.
amlodipine 5mg and folic acid 0.8mg daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shenzhen Ausa Pharmed Co.,Ltdlead
- Peking University First Hospitalcollaborator
- Chinese PLA General Hospitalcollaborator
- Capital Medical Universitycollaborator
- Fudan Universitycollaborator
- Ruijin Hospitalcollaborator
- Nanchang Universitycollaborator
- First Affiliated Hospital of Fujian Medical Universitycollaborator
- First Affiliated Hospital of Harbin Medical Universitycollaborator
- China Medical University, Chinacollaborator
- Xi'an Jiaotong Universitycollaborator
- Xuzhou Medical Universitycollaborator
- Anhui Medical Universitycollaborator
- Huazhong University of Science and Technologycollaborator
- West China Hospitalcollaborator
- Guangdong Provincial People's Hospitalcollaborator
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitycollaborator
Study Sites (16)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, 100029, China
Peking University First Hospital
Beijing, Beijing Municipality, 100036, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Guangdong General Hospital
Guangzhou, Guangdong, 510030, China
First Affiliated Hospital of Harbin Medical University
Haibin, Heilongjiang, 150001, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, 221006, China
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, 330006, China
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110002, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
First Affiliated Hospital of the School of Medicine, Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
West China School of Medicine, West China Hospital ,Sichuan University
Chengdu, Sichuan, 610041, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong Huo, MD
Peking University First Hospital, Beijing, CHINA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2013
First Posted
May 8, 2013
Study Start
January 1, 2013
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
May 8, 2013
Record last verified: 2013-05