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

• Conditions: patients with hypertension; MedDRA version: M15Level: LLTClassification code 10020772

• Registration Number: EUCTR2004-002534-18-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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:
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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified