An open, multicenter study to evaluate the efficacy and safety of a 4 week therapy with CoDiovan 160/25 (fixed dose combination of valsartan 160 mg plus HCTZ 25 mg) in patients not adequately responding to a 4 week monotherapy with olmesartan medoxomil 40 mg or combination therapy with olmesartan medoxomil 20 mg plus HCTZ 12.5 mg - VALORY

ovartis Pharma GmbH0 sitesOctober 12, 2004

Conditionspatients with hypertension MedDRA version: M15Level: LLTClassification code 10020772

DrugsCoDiovan forte 160mg/25mg Olmetec HCT Sandoz 12,5mg

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: patients with hypertension
Sponsor: ovartis Pharma GmbH
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 12, 2004

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharma GmbH

Eligibility 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 \< 110 mmHg and treated patients need to have a MSDBP \< 110 mmHg. Untreated patients can be included as soon as the safety laboratory parameters are available, but not at the day of Visit 1\. This inclusion visit will be recorded as Visit 3 in the CRF.
•\- At Visit 2, patients previously treated for hypertension need to have a MSDBP \>\= 100 mmHg and \< 110 mmHg for entrance into the first treatment phase. Patients previously treated for hypertension who have a MSDBP \< 100 mmHg at Visit 2 will continue the wash\-out phase and will be again evaluated with regard to BP criteria at Visit 3\. Untreated patients do not perform Visit 2\.
•\- At Visit 3, which is not performed for patients who entered the first treatment phase already at Visit 2, patients need to have a MSDBP \>\= 100 mmHg and \< 110 mmHg for entrance into the first treatment phase.
•\- At Visit 4, all patients need to have a MSDBP \>\= 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:

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