VALORY Study of Valsartan/Hydrochlorizide for Patients Who do Not Respond Adequately to Olmesartan Medoxomil

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171015
• Other study ID #: CVAH631BDE10
• Status: Completed
• Phase: Phase 3
• Start date: December 2004
• Est. completion date: April 2005

Study information

• Verified date: October 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• valsartan plus hydrochlorothiazide

Locations

Country	Name	City	State
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in diastolic blood pressure after 4 weeks
Secondary	Change from baseline in systolic blood pressure after 4 weeks
Secondary	Diastolic blood pressure less than 90 mmHg after 4 weeks
Secondary	Diastolic blood pressure less than 90 mmHg or decrease in diastolic blood pressure of 10 mmHg or greater after 4 weeks
Secondary	Change from baseline heart rate after 4 weeks