Hypertension MedDRA version: 17.0 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: Diuretics
Product Name: Diruetics
Pharmaceutical Form:
Trade Name: Beta Blockers
Product Name: Beta Blockers
Sponsors
Joint Research Compliance Office, Imperial College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any patients aged 18-80 years; ? History of any grade of hypertension for at least 1 year, including at least 3 months of constant antihypertensive medication (consisting of = 1 antihypertensive drugs, each administered in one dose daily), ? Relatively well controlled BP (? 150/90 mmHg and = 115/65 mmHg on usual medication) at randomisation and based on previous clinic records, in the last 3 months. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: BP levels > 150/90 mmHg or 20 mm Hg drop of systolic BP or a > 10 mm Hg drop of diastolic BP or both between 1 and 3 min after standing from the sitting position or a history of postural hypotension. ? Known Extreme dippers - fall of mean night time SBP > 30% of mean day time SBP ? Individuals with jobs which require night-time shift work. ? Pregnant women, women planning pregnancy and women not using adequate contraception. ? Patients with arrhythmia (irregular heartbeat) ? Patients required to take their medication at a certain time of day
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 12 weeks and 24 weeks after baseline; Secondary end point(s): • Mean 24 hour diastolic BP • Mean day-time ABPM systolic BP • Mean day-time ABPM diastolic BP • Mean night time ABPM systolic BP • Mean night time ABPM diastolic BP • Mean clinic – systolic BP • Mean clinic – diastolic BP • Concordance with taking drug treatment • Occurrence of side-effects and tolerability (based on self-reported serious adverse events) • Quality of life • Any differences in clinical events (GP or hospital visits, procedures and hospitalization) | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To detect if there is a 3mm Hg difference in average 24 hour systolic blood pressure when blood pressure lowering medications are taken in the evening compared with same medications taken in the morning.; Secondary Objective: To detect any differences in: • 24 hour Ambulatory Blood Pressure Monitoring (ABPM) diastolic Blood Pressure (DBP) • day-time ABPM Systolic BP (SBP) and DBP • night-time ABPM SBP and DBP • average clinic SBP and DBP • concordance with drug taking, • Occurrence of side-effects and tolerability (based on self-reported adverse effects) and quality of life. • Clinical events (extra GP or hospital visits and procedures and hospitalization) ;Primary end point(s): 3mm Hg difference in mean 24 hour systolic blood pressure;Timepoint(s) of evaluation of this end point: 12 weeks and 24 weeks after baseline | — |
Countries
Greece, United Kingdom
Contacts
Public ContactNabila Youssouf
Joint Research Compliance Office, Imperial College
Outcome results
None listed