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

NCT00171015 | Completed Phase 3

• 1 other identifier: CVAH631BDE10
• Study Type: interventional
• Target: 212
• Locations: 2 countries
• Sites: 2

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 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.

Conditions

Hypertension

Keywords

VALSARTAN; HYDROCHLOROTHIAZIDE; OLMESARTAN; HYPERTENSION

Outcome Measures

Primary Outcomes (1)

• Change from baseline in diastolic blood pressure after 4 weeks

Secondary Outcomes (4)

• 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

Interventions

valsartan plus hydrochlorothiazide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (2)

Unknown Facility

Multiple Locations, Germany

Location

Novartis Pharmaceuticals

Basel, Switzerland

Location

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 15, 2005
• Study Start: December 1, 2004
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

DE (1); CH (1)