Status:
COMPLETED
VALORY Study of Valsartan/Hydrochlorizide for Patients Who do Not Respond Adequately to Olmesartan Medoxomil
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate 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...
Eligibility Criteria
Inclusion
- 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).
- 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.
Exclusion
- MSDBP \>110 mmHg or MSSBP \>180 mmHg
- Pregnant or nursing women
- Inability to completely discontinue all antihypertensive medications safely for a period of up to 2 weeks, as required by the protocol
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT00171015
Start Date
December 1 2004
End Date
April 1 2005
Last Update
October 18 2023
Active Locations (2)
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1
Multiple Locations, Germany
2
Novartis Pharmaceuticals
Basel, Switzerland