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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171015
First received: September 10, 2005
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: valsartan plus hydrochlorothiazide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in diastolic blood pressure after 4 weeks

Secondary Outcome Measures:
  • 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

Enrollment: 212
Study Start Date: December 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171015

Locations
Germany
Investigative Centers, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171015     History of Changes
Other Study ID Numbers: CVAH631BDE10
Study First Received: September 10, 2005
Last Updated: November 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
VALSARTAN
HYDROCHLOROTHIAZIDE
OLMESARTAN
HYPERTENSION

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Valsartan
Olmesartan medoxomil
Olmesartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 26, 2014