Essential HypertensionPhase 2/3NCT01848873
Efficacy of Amlodipine-folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine
A Phase 2/3 study testing Amlodipine, amlodipine-FA tablet, low dose group and amlodipine-FA tablet ,high dose group in people with Essential Hypertension, run by Shenzhen Ausa Pharmed Co.,Ltd at 16 sites in China.
Trial summary
To evaluate the efficacy of Amlodipine-folic Acid Tablets on reduction of blood pressure and plasma homocystein. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Amlodipine, amlodipine-FA tablet, low dose group and amlodipine-FA tablet ,high dose group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- 16 sitesChina
- Study dates
- Jan 2013to Aug 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 23Show fewer
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, 100029
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100036
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
- Not yet recruiting
West China School of Medicine, West China Hospital ,Sichuan University
Chengdu, Sichuan, 610041
- Not yet recruiting
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
- Not yet recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510030
- Not yet recruiting
First Affiliated Hospital of Harbin Medical University
Haibin, Heilongjiang, 150001
- Not yet recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
- Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
- Not yet recruiting
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, 330006
- Not yet recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
- Not yet recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
- Not yet recruiting
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110002
- Not yet recruiting
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, 430022
- Not yet recruiting
First Affiliated Hospital of the School of Medicine, Xi'an Jiaotong University
Xi’an, Shanxi, 710061
- Recruiting
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, 221006
About this study
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
To evaluate the efficacy of Amlodipine-folic Acid Tablets on reduction of blood pressure and plasma homocystein.
Read the 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.
- Conditions
- Essential Hypertension
- Being tested
- Amlodipine, amlodipine-FA tablet, low dose group, amlodipine-FA tablet ,high dose group
- Keywords
- Hyperhomocysteinemia, Amlodipine-folic acid tablets, Hypertension, MTHFR C677T
- Medical subject headings
- Essential Hypertension, Hyperhomocysteinemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
Also called control
amlodipine 5mg daily
amlodipine-FA tablet, low dose groupDrug
Also called low dose
5mg amlodipine combined with 0.4 mg of folic acid, daily.
amlodipine-FA tablet ,high dose groupDrug
Also called high dose
amlodipine 5mg and folic acid 0.8mg daily
| Study group | Role | What they receive |
|---|---|---|
| amlodipine-FA tablet, low dose group | Experimental | 5mg amlodipine combined with 0.4 mg of folic acid (FA),once daily for 8 weeks. Receives: Drug: amlodipine-FA tablet, low dose group |
| amlodipine-FA tablet ,high dose group | Experimental | 5mg amlodipine combined with 0.8 mg of folic acid (FA), once daily for 8 weeks. Receives: Drug: amlodipine-FA tablet ,high dose group |
| amolodipine | Active comparator | 5 mg amlodipine, once daily for 8 weeks. Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined effective rate of blood pressure and plasma homocysteine reduction
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 756 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Ausa Pharmed Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital, Chinese PLA General Hospital, Capital Medical University, Fudan University, Ruijin Hospital, Nanchang University, First Affiliated Hospital of Fujian Medical University, First Affiliated Hospital of Harbin Medical University, China Medical University, China, Xi'an Jiaotong University, Xuzhou Medical University, Anhui Medical University, Huazhong University of Science and Technology, West China Hospital, Guangdong Provincial People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Sponsor
- Investigators
- Yong Huo, MD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848873
- Sponsor's protocol ID
- AUSA-amlodipine
- Status last verified
- May 2013
- First submitted
- 4 May 2013
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li J, Zhang Y, Fan F, Yi T, Cheng X, Bao H, Huang X, Chen Y, Xue H, Chen F, Wu C, Han Z, Cheng W, Gao P, Zhang J, Sheng C, Tian Y, Guo H, Wang Z, Yao C, Qin X, Tang G, Wang B, Cui Y, Wang J, Hou FF, Huo Y. Blood pressure and homocysteine-lowering effects of the amlodipine/folic acid combination in patients with hypertension and serum homocysteine concentration >/=10 mumol/l (H-type hypertension): a multicenter, randomized, double-blind, parallel-controlled clinical trial. J Hypertens. 2026 Aug 31. doi: 10.1097/HJH.0000000000004420. Online ahead of print.
PubMed 42861767
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01848873
- Acronym / sponsor ID
- AUSA-amlodipine
- Conditions
- Essential Hypertension
- Keywords
- Hyperhomocysteinemia, Amlodipine-folic acid tablets, Hypertension, MTHFR C677T
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 756 participants (estimated)
- Lead sponsor
- Shenzhen Ausa Pharmed Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital, Chinese PLA General Hospital, Capital Medical University, Fudan University, Ruijin Hospital, Nanchang University, First Affiliated Hospital of Fujian Medical University, First Affiliated Hospital of Harbin Medical University, China Medical University, China, Xi'an Jiaotong University, Xuzhou Medical University, Anhui Medical University, Huazhong University of Science and Technology, West China Hospital, Guangdong Provincial People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 8 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of Amlodipine-folic Acid Tablets on reduction of blood pressure and plasma homocystein.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| amlodipine-FA tablet, low dose group | Experimental | Drug: amlodipine-FA tablet, low dose group5mg amlodipine combined with 0.4 mg of folic acid (FA),once daily for 8 weeks. |
| amlodipine-FA tablet ,high dose group | Experimental | Drug: amlodipine-FA tablet ,high dose group5mg amlodipine combined with 0.8 mg of folic acid (FA), once daily for 8 weeks. |
| amolodipine | Active comparator | Drug: Amlodipine5 mg amlodipine, once daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmlodipineAlso: controlamlodipine 5mg daily | Drug | amolodipine |
| amlodipine-FA tablet, low dose groupAlso: low dose5mg amlodipine combined with 0.4 mg of folic acid, daily. | Drug | amlodipine-FA tablet, low dose group |
| amlodipine-FA tablet ,high dose groupAlso: high doseamlodipine 5mg and folic acid 0.8mg daily | Drug | amlodipine-FA tablet ,high dose group |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
- Derived from this study: PubMed 42861767Li J, Zhang Y, Fan F, Yi T, Cheng X, Bao H, Huang X, Chen Y, Xue H, Chen F, Wu C, Han Z, Cheng W, Gao P, Zhang J, Sheng C, Tian Y, Guo H, Wang Z, Yao C, Qin X, Tang G, Wang B, Cui Y, Wang J, Hou FF, Huo Y. Blood pressure and homocysteine-lowering effects of the amlodipine/folic acid combination in patients with hypertension and serum homocysteine concentration >/=10 mumol/l (H-type hypertension): a multicenter, randomized, double-blind, parallel-controlled clinical trial. J Hypertens. 2026 Aug 31. doi: 10.1097/HJH.0000000000004420. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Huo, MD principal investigator
Peking University First Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amlodipine, amlodipine-FA tablet, low dose group and amlodipine-FA tablet ,high dose group in people with Essential Hypertension, run by Shenzhen Ausa Pharmed Co.,Ltd at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Huo, MD (86-10-66551122-2704, huoyong18@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01848873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2013.