VALORY Study of Valsartan/Hydrochlorizide for Patients Who do Not Respond Adequately to Olmesartan Medoxomil
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00171015|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 8, 2011
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: valsartan plus hydrochlorothiazide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||212 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open,Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With Valsartan/Hydrochlorothiazide 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|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||April 2005|
|Actual Study Completion Date :||April 2005|
- Change from baseline in diastolic blood pressure after 4 weeks
- Change from baseline in systolic blood pressure after 4 weeks
- Diastolic blood pressure less than 90 mmHg after 4 weeks
- Diastolic blood pressure less than 90 mmHg or decrease in diastolic blood pressure of 10 mmHg or greater after 4 weeks
- Change from baseline heart rate after 4 weeks
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171015
|Investigative Centers, Germany|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|
|Other Study ID Numbers:||
|First Posted:||September 15, 2005 Key Record Dates|
|Last Update Posted:||November 8, 2011|
|Last Verified:||November 2011|
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators