- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00171015
VALORY Study of Valsartan/Hydrochlorizide for Patients Who do Not Respond Adequately to Olmesartan Medoxomil
October 17, 2023 updated by: Novartis
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
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 HCTZ 12.5 mg by testing the hypothesis that valsartan 160 mg/HCTZ 25 mg significantly reduces the trough mean sitting diastolic blood pressure (MSDBP) after a 4-week treatment in the nonresponder population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
212
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Multiple Locations, Germany
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Basel, Switzerland
- Novartis Pharmaceuticals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change from baseline in diastolic blood pressure after 4 weeks
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Secondary Outcome Measures
Outcome Measure |
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Change from baseline in systolic blood pressure after 4 weeks
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Diastolic blood pressure less than 90 mmHg after 4 weeks
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Diastolic blood pressure less than 90 mmHg or decrease in diastolic blood pressure of 10 mmHg or greater after 4 weeks
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Change from baseline heart rate after 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
April 1, 2005
Study Completion (Actual)
April 1, 2005
Study Registration Dates
First Submitted
September 10, 2005
First Submitted That Met QC Criteria
September 10, 2005
First Posted (Estimated)
September 15, 2005
Study Record Updates
Last Update Posted (Actual)
October 18, 2023
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Valsartan
- Hydrochlorothiazide
Other Study ID Numbers
- CVAH631BDE10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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