Efficacy of Amlodipine-Folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine
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|ClinicalTrials.gov Identifier: NCT01956786|
Recruitment Status : Unknown
Verified July 2013 by Shenzhen Ausa Pharmed Co.,Ltd.
Recruitment status was: Recruiting
First Posted : October 8, 2013
Last Update Posted : October 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Essential Hypertension||Drug: Amlodipine-FA tablet,low dose group Drug: Amlodipine-FA tablet,high dose group Drug: Amlodipine||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||September 2013|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||February 2014|
Active Comparator: Amlodipine
5mg amlodipine,once daily for 8 weeks
5mg amlodipine,once daily
Other Name: control
Experimental: Amlodipine-FA tablet,low dose group
5mg amlodipine combined with 0.4mg of folic acid (FA),once daily for 8 weeks.
Drug: Amlodipine-FA tablet,low dose group
5mg amlodipine combined with 0.4mg folic acid,once daily (Low-dose group)
Other Name: low dose
Experimental: Amlodipine-FA tablet,high dose group
5mg amlodipine combined with 0.8mg of folic acid (FA),once daily for 8 weeks.
Drug: Amlodipine-FA tablet,high dose group
5mg amlodipine combined with 0.8mg folic acid,once daily (High-dose group)
Other Name: high dose
- 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. ]
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956786
|The Affiliated Hospital of Xuzhou Medical College||Not yet recruiting|
|Xuzhou, Jiangsu, China, 221006|
|Contact: Wang Zhirong, MD 86-0516-85802111 email@example.com|
|Principal Investigator: Wang Zhirong, MD|
|The Second Affiliated Hospital of Nanchang University||Recruiting|
|Nanchang, Jiangxi, China, 330006|
|Contact: Cheng Xiaoshu, MD 86-791-6268844 firstname.lastname@example.org|
|Principal Investigator: Cheng Xiaoshu, MD|
|Ruijin Hospital, Shanghai Jiao Tong Univesity||Recruiting|
|Shanghai, Shanghai, China, 310000|
|Contact: Wang Jiguang, MD 86-021-64370045 email@example.com|
|Principal Investigator: Wang Jiguang, MD|
|Principal Investigator:||Wang Jiguang, MD||Ruijin Hospital, Shanghai Jiao Tong University|