hypertension MedDRA version: 9.1 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Interventions
Trade Name: DELAKET 15*28CPR 15MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Delapril
CAS Number: 83435-66-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
CHIESI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients aged 18-75 inclusive Patients with mild to moderate hypertension defined as a mean sitting diastolic blood pressure DBP within the range of 95-109 mmHg included and mean sitting systolic blood pressure SBP inferior or equal to 179 mmHg. Patients with DBP below the above described value and whose current therapy is not providing adequate control or is producing unacceptable side effects 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Severe hypertension or secondary Orthostatic hypotension History of malignant hypertension History of miocardial infarction or coronary revascularization procedures within the last 3 months Angine pectoris requiring more than short acting nitrates, grade III and IV congestive heart failure, hemodinamically significant valvular heart disease, clinically relevant cardiac conduction abnormalities, including bradycardia, tachicardia, ventricular arrythmias History of stroke or TIA Obesity with BMI 32 Unstable diabetes with retinophaty or peripheral neuropathy and/or with insulin treatment Severe impaired liver function, renal impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To establish the superiority of Delapril 30 mg b.i.d. in forced titration over Delapril 15 mg bid. To establish the superiority of the three active groups over placebo.;Primary end point(s): Mean change from baseline visit 2 to the final visit visit 6 in sDBP;Main Objective: To establish the non-inferiority of Delapril 30 mg administered twice daily compared to Lisinopril 20 mg administered once daily in terms of DBP reduction after 12 weeks of treatment with a forced titration regimen for both treatments groups after 6 weeks | — |
Countries
Italy
Outcome results
None listed