Efficacy of Amlodipine-folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine
Recruitment status was: Recruiting
|Essential Hypertension||Drug: Amlodipine Drug: amlodipine-FA tablet, low dose group Drug: amlodipine-FA tablet ,high dose group||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- 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 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. ]
- 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. ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: amlodipine-FA tablet, low dose group
5mg amlodipine combined with 0.4 mg of folic acid (FA),once daily for 8 weeks.
Drug: amlodipine-FA tablet, low dose group
5mg amlodipine combined with 0.4 mg of folic acid, daily.
Other Name: low dose
Experimental: amlodipine-FA tablet ,high dose group
5mg amlodipine combined with 0.8 mg of folic acid (FA), once daily for 8 weeks.
Drug: amlodipine-FA tablet ,high dose group
amlodipine 5mg and folic acid 0.8mg daily
Other Name: high dose
Active Comparator: amolodipine
5 mg amlodipine, once daily for 8 weeks.
amlodipine 5mg daily
Other Name: control
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01848873
|Contact: Yong Huo, MDfirstname.lastname@example.org|
|Contact: Yan Zhang, MDemail@example.com|
|The First Affiliated Hospital of Anhui Medical University||Not yet recruiting|
|Hefei, Anhui, China, 230022|
|Anzhen Hospital,Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100029|
|Peking University First Hospital||Recruiting|
|Beijing, Beijing, China, 100036|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|First Affiliated Hospital of Fujian Medical University||Not yet recruiting|
|Fuzhou, Fujian, China, 350005|
|Guangdong General Hospital||Not yet recruiting|
|Guangzhou, Guangdong, China, 510030|
|First Affiliated Hospital of Harbin Medical University||Not yet recruiting|
|Haibin, Heilongjiang, China, 150001|
|Union Hospital, Tongji Medical College,Huazhong University of Science and Technology||Not yet recruiting|
|Wuhan, Hubei, China, 430022|
|The Affiliated Hospital of Xuzhou Medical College||Recruiting|
|Xuzhou, Jiangsu, China, 221006|
|The Second Affiliated Hospital Of Nanchang University||Not yet recruiting|
|Nanchang, Jiangxi, China, 330006|
|First Affiliated Hospital of China Medical University||Not yet recruiting|
|Shenyang, Liaoning, China, 110002|
|Ruijin Hospital, Shanghai Jiaotong University School of Medicine||Not yet recruiting|
|Shanghai, Shanghai, China, 200025|
|Zhongshan Hospital Fudan University||Not yet recruiting|
|Shanghai, Shanghai, China, 200032|
|First Affiliated Hospital of the School of Medicine, Xi'an Jiaotong University||Not yet recruiting|
|Xi'an, Shanxi, China, 710061|
|West China School of Medicine, West China Hospital ,Sichuan University||Not yet recruiting|
|Chengdu, Sichuan, China, 610041|
|Second Affiliated Hospital, School of Medicine, Zhejiang University||Not yet recruiting|
|Hangzhou, Zhejiang, China, 310009|
|Principal Investigator:||Yong Huo, MD||Peking University First Hospital, Beijing, CHINA|