BP lowering effect of chlorthalidone 25 mg in essential hypertensive patients. MedDRA version: 19.0 Level: LLT Classification code 10045866 Term: Unspecified essential hypertension System Organ Class: 100000004866
Conditions
Interventions
Product Name: Unidone Tablets 25mg/tab
Pharmaceutical Form: Tablet
INN or Proposed INN: CHLORTHALIDONE
Other descriptive name: CHLORTALIDONE
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study population consists of 40 subjects (18 =65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: Exclusion criteria include patients below 18 or above 75 years old, with secondary forms of hypertension, history of myocardial infarction, unstable angina pectoris, a cerebrovascular accident within 6 months, hemodynamically significant valvular heart disease, chronic kidney disease (defined as eGFR<45 ml/min/1.73m2), severe systemic disease, bleeding disorders, pregnancy or lactation and scheduled surgery or cardiovascular intervention in the next 6 months. Additionally, hypertensive patients with current treatment with any type of diuretic, except antialdosterone agents, and previous documented intolerance to diuretics, will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to address the BP lowering effect of chlorthalidone 25 mg in essential hypertensive patients. In parallel, safety following chlorthalidone administration will be evaluated in the patients that will be enrolled in the study. In specific: Primary efficacy end-points 1.Changes in Office BP at 4 and 12 weeks. 2.Patients with controlled hypertension at 12 weeks. Primary safety end-points 1.Changes in renal function by means of serum creatinine, estimated glomerular filtration rate (eGFR) and albuminuria at 4 and 12 weeks. 2.Changes in serum sodium, potassium and calcium levels at 4 and 12 weeks. 3.Changes in glycemic, lipid profile as well as uric acid levels at 4 and 12 weeks. 4.Hypotension episodes during follow-up. 5.Hospitalization for cardiovascular or any other systemic disease during follow-up.;Secondary Objective: Secondary efficacy end-point 1.Changes in ambulatory BP at 4 and 12 weeks (performed in a subgroup of patients).;Primary end point(s): Examination at 4 weeks of therapy Patients will be examined and office systolic/diastolic BP will be evaluated. If office systolic BP =140 mmHg and/or office diastolic BP=90 mmHg step up of therapy with chlorthalidone 50 mg is in the discretion of the investigators. Examination at 12 weeks of therapy Patients will be examined in this final study visit and office systolic/diastolic BP will be evaluated along with metabolic profile determination. The percentage of patients with hypertension control (office BP<140/90 mmHg) will be estimated. The following safety clinical criteria will be evaluated: •Changes in renal function by means of serum creatinine, estimated glomerular filtration rate (eGFR) and albuminuria at 4 and 12 weeks. •Changes in serum sodium, potassium and calcium levels at 4 and 12 weeks. •Changes in glycemic, lipid profile as well as uric acid levels at 4 and 12 weeks. •Hypotension episodes during follow-up. •Hospitalization for cardiovascular or any ot | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In 1 out 4 consecutive patients ambulatory BP will be also evaluated on all time points of the study along with metabolic profile determination. Study assessments 4 weeks: Ambulatory BP in subgroup of 10 patients 12 weeks (end of study): Ambulatory BP in subgroup of 10 patients;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Greece
Contacts
Public ContactRegulatory Affairs department
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Outcome results
None listed