patients with hypertension MedDRA version: M15 Level: LLT Classification code 10020772
Conditions
Interventions
Trade Name: CoDiovan forte 160mg/25mg
Product Name: CoDiovan 160mg/25mg
Product Code: Valsartan/HCTZ
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Valsartan/Hydrochlorothiazid
Current S
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients >= 18 years 2. Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives). 3. Patients with essential hypertension: - At Visit 1, untreated patients should have a MSDBP >= 100 mmHg and = 100 mmHg and = 100 mmHg and = 90 mmHg for entrance into the second treatment phase 4. Written informed consent to participate in the study prior to any study procedures 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: 1. MSDBP >= 110 mmHg or MSSBP >= 180 mmHg 2. Pregnant or nursing women 3. Treated hypertensive patients with controlled hypertension under current therapy (MSDBP < 90 mmHg and MSSBP < 140 mmHg) 4. History of hypertensive encephalopathy or cerebrovascular accident within the preceding 12 months 5. Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral renal artery stenosis or pheochromocytoma 6. Known or suspected contraindications including history of allergy to angiotensin II receptor blockers or to diuretics as described in the basic product information (particularly olmesartan medoxomil 20 mg or 40 mg, valsartan 160 mg) 7. Heart failure NYHA II-IV 8. Concomitant refractory angina pectoris, potentially life-threatening arrhythmia or symptomatic arrhythmia or clinically significant valvular heart disease 9. Transient ischemic cerebral attack, stroke or myocardial infarction during the last 12 months prior to Visit 1 10. Type 1 diabetes mellitus or poorly controlled Type 2 DM 11. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug. 12. Patient with history of malignancy of any organ system, treated or untreated, within the past five years, whether or not evidence of local recurrence or metastases exists, are excluded, with the exception of localized basal cell carcinoma of the skin 13. Participation in any investigational drug trial within one month prior to Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of valsartan 160 mg/HCTZ 25 mg in patients not adequately responding to monotherapy with olmesartan medoxomil 40 mg or combination therapy with olmesartan medoxomil 20 mg plus HCTZ 12.5 mg by testing the hypothesis that valsartan 160 mg/HCTZ 25 mg is significantly reducing the trough mean sitting diastolic blood pressure (MSDBP) after a 4-week treatment in the non-responder population.;Secondary Objective: To explore the efficacy of valsartan 160 mg/HCTZ 25 mg in patients not adequately responding to monotherapy with olmesartan medoxomil 40 mg or combination therapy with olmesartan medoxomil 20 mg plus HCTZ 12.5 mg by testing the hypothesis that: - valsartan 160 mg/HCTZ 25 mg is significantly reducing the trough mean sitting systolic blood pressure (MSSBP) after a 4-week treatment in the non-responder population, - valsartan 160 mg/HCTZ 25 mg is leading to higher normalization rate (defined as a MSDBP < 90 mmHg) and responder rate (defined as a MSDBP < 90 mmHg or ? 10 mmHg decrease compared to Visit 4) in the non-responder population after a 4-week treatment, To explore the safety of valsartan 160 mg/HCTZ 25 mg in patients not adequately responding to monotherapy with olmesartan medoxomil 40 mg or combination therapy with olmesartan medoxomil 20 mg plus HCTZ 12.5 mg by testing the hypothesis of comparable rates of adverse events and lab changes. ;Primary end point(s): The primary efficacy parameter of this trial is the change in trough MSDBP between Visit 4 (olmesartan medoxomil 40 mg or olmesartan medoxomil 20 mg plus HCTZ 12.5 mg) and Visit 5 (valsartan 160 mg/HCTZ 25 mg). | — |
Countries
Germany
Outcome results
None listed