Hypertensive patients not adequately responding to a 4 week therapy with candesartan 32 mg plus hydrochlorothiazide 25 mg MedDRA version: 9.1 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Interventions
Trade Name: Blopress
Product Name: Candesartan
Pharmaceutical Form: Tablet
INN or Proposed INN: Candesartancilexetil
CAS Number: 145040-37-5
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients ? 18 years 2. Patients with essential hypertension: - At Visit 1, untreated patients must have an MSDBP ? 100 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with controlled blood pressure levels (MSSBP 11 mmol/l or > 200 mg/dl at Visit 1. 15. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug. 16. Therapy resistant hypokalemia, hypercalcemia, symptomatic hyperuricemia or sodium depletion ( 5 mIU/ml)) o who are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception (Pearl Index <1**) during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for all women and for girls entering menarche is required with sufficient lead time before inclusion *definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH leve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that 4 weeks of treatment with aliskiren 300mg plus hydrochlorothiazide 25mg in combination provide an additional mean sitting diastolic blood pressure reduction in hypertensive patients not adequately responding (i.e., MSDBP > 90 mmHg) to 4 weeks of treatment with an agiontensin receptor blocker plus hydrochlorothiazide 25mg in combination (candesartan 32mg plus HCTZ 25mg);Secondary Objective: To evaluate the effects of 4 weeks of treatment with aliskiren 300mg plus HCTZ 25mg in combination in patients not adequately responding (i.e., MSDBP > 90 mmHg) to 4 weeks of treatment with candesartan 32mg plus HCTZ 25mg in combination on the difference in mean sitting systolic blood pressure, pulse pressure, heart rate, normalization and responder rate. To assess the safety and tolerability of aliskiren 300mg plus HCTZ 25mg.;Primary end point(s): The aim of this multicenter open-label trial is to evaluate the reduction in trough MSDBP by a 4-week treatment with aliskiren 300 mg plus HCTZ 25 mg in hypertensive patients not adequately controlled by candesartan 32 mg plus HCTZ 25 mg. The main interest is the estimation and testing of the changes in BP between Visit 4 and Visit 5. The primary efficacy parameter of this trial is the change in trough MSDBP between Visit 4 (candesartan 32 plus HCTZ 25 mg) and Visit 5 (aliskiren 300 mg plus HCTZ 25 mg). | — |
Countries
Germany
Outcome results
None listed