Patients with hyperhomocysteinemia and high-normal blood pressure, otherwise healthy
Conditions
Interventions
Trade Name: Folsan 5mg
Product Name: Folsan 5mg
Pharmaceutical Form: Tablet
INN or Proposed INN: folic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Pharmaceutical form of the pla
Sponsors
Organisation name was not entered
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with hyperhomocysteinemia and high normal systolic (> 135mmHg) and/or diastolic (>85mmHg) blood pressure Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Smoker (> 5/d), alcoholism, high coffee or tee consumption (>500ml/d), obesity (BMI >30kg/m²), hypertension that need to be treated or allredy treated, suspected or known secondary origin of hypertension, high LDL-Cholesterol (>160mg/dl), diabetes mellitus, megaloblast anemia, regular medication (with exception of oral anticontraception) or vitamin substitution, participation in an other clinical trial within the last 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proof of effectivenes to reduce a high-normal blood pressure by supplementation of folic acid 5mg in persons with hyperhomocysteinemia.;Secondary Objective: Correlation of blood pressure reduction with reduction of hyperhomocysteinemia;Primary end point(s): Reduction of systolic blood pressure after supplementation of 5mg folic acid for 8 weeks as compared to placebo (substudy A). Reduction of diastolic blood pressure after supplementation of 5mg folic acid for 8 weeks as compared to placebo (substudy B). | — |
Countries
Germany
Outcome results
None listed