A Phase 2 interventional study of Active treatment with nitrendipine (10-40 mg/day). in Isolated Systolic Hypertension, sponsored by KU Leuven. Terminated. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2017-05-11.
Sponsored by KU Leuven · Phase 2, Interventional, and Treatment
The Syst-Eur Trial is a concerted action of the European Community's Medical and Health Research Programme. The trial is carried out in consultation with the World Health Organization, the International Society of Hypertension, the European Society of Hypertension and the World Hypertension League. Syst-Eur is a multicentre trial designed by the European Working Party on High Blood Pressure in the Elderly (EWPHE), to test the hypothesis that antihypertensive treatment of elderly patients with isolated systolic hypertension results in a significant change in stroke morbidity and mortality. Secondary endpoints include cardiovascular events, such as myocardial infarction and congestive heart failure. To be eligible patients must be at least 60 years old and have a systolic blood pressure averaging 160-219 mmHg with a diastolic pressure less than 95 mmHg. Patients must give their informed consent and be free of major cardiovascular and non-cardiovascular diseases at entry. The patients are randomized to active treatment or placebo. Active treatment consists of nitrendipine (10-40 mg/day), combined with enalapril (5-20 mg/day) and hydrochlorothiazide (12.5-25 mg/day), as necessary. The patients of the control group receive matching placebos. The drugs (or matching placebos) are stepwise titrated and combined in order to reduce systolic blood pressure by 20 mmHg at least to a level below 150 mmHg. Morbidity and mortality are monitored to enable an intention-to-treat and per-protocol comparison of the outcome in the 2 treatment groups.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 4,695 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.
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Exclusion Criteria:
Active treatment with nitrendipine (10-40 mg/day). If necessary, the dihydropyridine calcium-channel blocker was combined with or replaced by enalapril maleate (5-20 mg/day), hydrochlorothiazide (12.5-25 mg/day), or both drugs.
Drug: Active treatment with nitrendipine (10-40 mg/day).
Placebo tablets were identical to the study drugs with a similar schedule.
Drug: Active treatment with nitrendipine (10-40 mg/day).
If necessary, the dihydropyridine calcium-channel blocker was combined with or replaced by enalapril maleate (5-20 mg/day), hydrochlorothiazide (12.5-25 mg/day), or both drugs.
Incidence of stroke
Available in Lancet 1997; 350:757-764
Time frame: 3-monthly visits up to 5 years
Death
Available in Lancet 1997; 350:757-764
Time frame: 3-monthly visits up to 5 years
Myocardial infarction
Available in Lancet 1997; 350:757-764
Time frame: 3-monthly visits up to 5 years
Congestive heart failure
Available in Lancet 1997; 350:757-764
Time frame: 3-monthly visits up to 5 years
No study locations are listed for this record.
Plan to share: Yes — Syst-Eur data are available on request by other investigators, whose research is ethically approved.
This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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KU Leuven