Plasma Total Homocysteine LevelPhase 2NCT00520247
Effect of Enalapril Plus Folic Acid on Blood Pressure and Glycometabolism
A Phase 2 study testing enalapril plus folic acid in people with Plasma Total Homocysteine Level and Blood Pressure, run by Anhui Medical University at 1 site in China.
Trial summary
Combinded therapy with folic acid and enalapril may significantly decrease plasma total homocysteine level and had beneficial effect on blood pressure reduction and glycometabolism. Read more about this study
- Who is it for?
- Ages 28 to 75 years
- Conditions the study is for
- Plasma Total Homocysteine Level, Blood Pressure
- What is being tested?
- enalapril plus folic acid
- How many people
- 443 participants
- Where
- 1 siteChina
- Study dates
- Sep 2005to Feb 2006
- Phase
- Phase 2
- 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 28 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years and less than 75 years
- Essential hypertension patients
- Sedentary systolic blood pressure≥140mmHg and less than 180mmHg, and/or sedentary diastolic blood pressure≥90mmHg and less than 110mmHg
- Reproductive women agree to take a reliable contraception measure during the trial
- Written informed consent
Who cannot join
- Pregnant women
- Women within lactateion period
- Hypersensitive to angiotensin-converting enzyme inhibitor (ACEI) or folic acid
- Easily hypersensitiveness
- Diagnosed secondum hypertension or skeptical secondum hypertension
- Severe hypertension (sedentary systolic blood pressure≥180mmHg and/or sedentary diastoleic blood pressure≥110mmHg)
Show all 35Show fewer
- 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, ventricular arrhythmia above Lown Ⅱ, 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≥200mmol/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:
- Chronic cough
- 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
- Taking other antihypertensive drugs
- Taking folic acid or other Vitamin B groups
Trial locations and contacts
1 site in 1 country.
China1 site
Inistitute for Biomedicine, Anhui Medical University
Hefei, Anhui, 230032
About this study
Official title: Efficacy of Antihypertensive and Plasma Total Homocysteine Lowering Combined Therapy With Enalapril and Folic Acid in Hypertensive Patients:A Multicenter Double Blind Randomized Clinical Trial
Combinded therapy with folic acid and enalapril may significantly decrease plasma total homocysteine level and had beneficial effect on blood pressure reduction and glycometabolism.
Read the detailed description
Inclusion Criteria:
- Age≥18 years and less than 75 years
- Essential hypertension patients
- Sedentary systolic blood pressure≥140mmHg and less than 180mmHg, and/or sedentary diastolic blood pressure≥90mmHg and less than 110mmHg
- Reproductive women agree to take a reliable contraception measure during the trial
- Written informed consent
Exclusion Criteria:
- Pregnant women
- Women within lactateion period
- Hypersensitive to Angiotensin-Converting Enzyme Inhibitor (ACEI) or folic acid
- Easily hypersensitiveness
- Diagnosed secondum hypertension or skeptical secondum hypertension
- Severe hypertension (sedentary systolic blood pressure greater than or equal to 180 mmHg and/or sedentary diastoleic blood pressure greater than or equal to 110 mmHg)
- Severe diseases:
- Cardiovascular system
- Diagnosed cardia insufficiency (New York Health Association [NYHA] III 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, ventricular arrhythmia above Lown ?, atrioventricular block above II level, etc.
- Alimentary system disorders
- 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) greater than 30 g/L
- Stomach bulk resect and gastrojejunostomy, stomach intestine malabsorption Urinary system:
- Serum creatinine greater than or equal to 200 mmol/L
- Diagnosed stenosis of renal artery, solitary kidney
- Renal transplantation Endocrine system:
- Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (fasting glucose greater than or equal to 11.1 mmol/L)
- Diagnosed and uncontrolled hyperthyrosis Respiratory system:
- Chronic cough 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, etc.
- Taking other antihypertensive drugs
- Taking folic acid or other Vitamin B groups
Primary Outcome Measures:
- Blood pressure of study participants was measured at baseline, 2th week, 4th week, 6th week and at the end of trial
- Subjects' plasma total homocysteine concentration were measured at baseline, 4th week and at 8th week.
Secondary Outcome Measures:
- Participants' living habit and life style were collected at baseline with the original questionnaires.
- A follow up questionnaire was sent out at 2th week, 4th week, 6th week and at the end of the trial.
- Conditions
- Plasma Total Homocysteine Level, Blood Pressure
- Being tested
- enalapril plus folic acid
- Keywords
- enalapril, folic acid, hyperglycemia, hypertension, fasting plasma glucose
- Medical subject headings
- Hyperglycemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enalapril plus folic acidDrug
enalapril 10.0 mg daily for 8 weeks (the control group); enalapril 10.0 mg plus folic acid 0.4 mg daily for 8 weeks (Low-dose group); enalapril 10.0 mg plus folic acid 0.8 mg daily for 8 weeks (High-dose group)
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure of study participants was measured at baseline, 2th week, 4th week, 6th week and at the end of trial Subjects' plasma total homocysteine concentration were measured at baseline, 4th week and at 8th week.
Measured: 8 weeks
Secondary outcomes (1)
Participants' living habit and life style were collected at baseline with the original questionnaires. A follow up questionnaire was sent out at 2th week, 4th week, 6th week and at the end of the trial.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startSep 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Total Homocysteine LevelStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Huashan Hospital, Harbin Medical University, China Medical University Hospital, First Affiliated Hospital Xi'an Jiaotong University, Nanjing Medical University
- Investigators
- Ping Liu, Dr., Study director, Peking University First Hopital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520247
- Sponsor's protocol ID
- 2005L01101
- Status last verified
- Aug 2007
- First submitted
- 17 Aug 2007
- Last updated
- 23 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Antihypertensive and Plasma Total Homocysteine Lowering Combined Therapy With Enalapril and Folic Acid in Hypertensive Patients:A Multicenter Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00520247
- Acronym / sponsor ID
- 2005L01101
- Conditions
- Plasma Total Homocysteine Level, Blood Pressure
- Keywords
- enalapril, folic acid, hyperglycemia, hypertension, fasting plasma glucose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Huashan Hospital, Harbin Medical University, China Medical University Hospital, First Affiliated Hospital Xi'an Jiaotong University, Nanjing Medical University
- Study start
- Sep 2005
- Study completion
- Feb 2006 (actual)
- First posted
- 23 Aug 2007 (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.
Combinded therapy with folic acid and enalapril may significantly decrease plasma total homocysteine level and had beneficial effect on blood pressure reduction and glycometabolism.
Detailed description
Inclusion Criteria:
- Age≥18 years and less than 75 years
- Essential hypertension patients
- Sedentary systolic blood pressure≥140mmHg and less than 180mmHg, and/or sedentary diastolic blood pressure≥90mmHg and less than 110mmHg
- Reproductive women agree to take a reliable contraception measure during the trial
- Written informed consent
Exclusion Criteria:
- Pregnant women
- Women within lactateion period
- Hypersensitive to Angiotensin-Converting Enzyme Inhibitor (ACEI) or folic acid
- Easily hypersensitiveness
- Diagnosed secondum hypertension or skeptical secondum hypertension
- Severe hypertension (sedentary systolic blood pressure greater than or equal to 180 mmHg and/or sedentary diastoleic blood pressure greater than or equal to 110 mmHg)
- Severe diseases:
- Cardiovascular system
- Diagnosed cardia insufficiency (New York Health Association [NYHA] III 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, ventricular arrhythmia above Lown ?, atrioventricular block above II level, etc.
- Alimentary system disorders
- 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) greater than 30 g/L
- Stomach bulk resect and gastrojejunostomy, stomach intestine malabsorption Urinary system:
- Serum creatinine greater than or equal to 200 mmol/L
- Diagnosed stenosis of renal artery, solitary kidney
- Renal transplantation Endocrine system:
- Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (fasting glucose greater than or equal to 11.1 mmol/L)
- Diagnosed and uncontrolled hyperthyrosis Respiratory system:
- Chronic cough 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, etc.
- Taking other antihypertensive drugs
- Taking folic acid or other Vitamin B groups
Primary Outcome Measures:
- Blood pressure of study participants was measured at baseline, 2th week, 4th week, 6th week and at the end of trial
- Subjects' plasma total homocysteine concentration were measured at baseline, 4th week and at 8th week.
Secondary Outcome Measures:
- Participants' living habit and life style were collected at baseline with the original questionnaires.
- A follow up questionnaire was sent out at 2th week, 4th week, 6th week and at the end of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 28 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age≥18 years and less than 75 years
- Essential hypertension patients
- Sedentary systolic blood pressure≥140mmHg and less than 180mmHg, and/or sedentary diastolic blood pressure≥90mmHg and less than 110mmHg
- Reproductive women agree to take a reliable contraception measure during the trial
- Written informed consent
Key exclusion criteria (35 listed)
- Pregnant women
- Women within lactateion period
- Hypersensitive to angiotensin-converting enzyme inhibitor (ACEI) or folic acid
- Easily hypersensitiveness
- Diagnosed secondum hypertension or skeptical secondum hypertension
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 |
|---|---|---|
| enalapril plus folic acidenalapril 10.0 mg daily for 8 weeks (the control group); enalapril 10.0 mg plus folic acid 0.4 mg daily for 8 weeks (Low-dose group); enalapril 10.0 mg plus folic acid 0.8 mg daily for 8 weeks (High-dose group) | Drug | – |
Primary outcome
Blood pressure of study participants was measured at baseline, 2th week, 4th week, 6th week and at the end of trial Subjects' plasma total homocysteine concentration were measured at baseline, 4th week and at 8th week.
Time frame: 8 weeks
1 secondary outcome
Participants' living habit and life style were collected at baseline with the original questionnaires. A follow up questionnaire was sent out at 2th week, 4th week, 6th week and at the end of the trial.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2007.
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.
Ping Liu, Dr. study director
Peking University First Hopital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing enalapril plus folic acid in people with Plasma Total Homocysteine Level and Blood Pressure, run by Anhui Medical University at 1 site 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 5 inclusion and 35 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: finished, as of the sponsor's last update on 23 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure of study participants was measured at baseline, 2th week, 4th week, 6th week and at the end of trial Subjects' plasma total homocysteine concentration were measured at baseline, 4th week and at 8th week. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2007.