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VALID: Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan Compared to Irbesartan in Patients With Mild to Moderate Hypertension on Long-term Hemodialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171080
First received: September 10, 2005
Last updated: November 7, 2011
Last verified: November 2011

September 10, 2005
November 7, 2011
April 2004
March 2006   (final data collection date for primary outcome measure)
Change from baseline in systolic blood pressure after 4 weeks
Not Provided
Complete list of historical versions of study NCT00171080 on ClinicalTrials.gov Archive Site
  • Change from baseline in diastolic blood pressure after 4 weeks
  • Systolic blood pressure less than 100 mmHg with or without symptoms of low blood pressure
  • Adverse events and clinical laboratory abnormal results
  • Change from baseline in average 24-hour ambulatory blood pressure after 4 weeks
  • Change from baseline in daytime and nighttime ambulatory blood pressures after 4 weeks
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VALID: Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan Compared to Irbesartan in Patients With Mild to Moderate Hypertension on Long-term Hemodialysis
A 2 x 5-week Multicenter, Cross-over Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan 80 mg Compared to Irbesartan 150 mg in Patients With Mild to Moderate Hypertension on Long-term Hemodialysis

The purpose of the study is to compare the efficacy, safety and tolerability of valsartan 80 mg (with a starting dose of 40 mg) to irbesartan 150 mg (with a starting dose of 75 mg) in patients on long-term haemodialysis with mild to moderate increased mean supine systolic blood pressure (MSSBP).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • Drug: valsartan
  • Drug: irbesartan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
March 2006
March 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with mild and moderate hypertension defined by a MSSBP ≥ 140 mmHG and < 180 mmHG at Visits 1 and 2 for treated and untreated patients
  • Chronic hemodialysis for at least 6 months prior to Visit 1 as substitution therapy.
  • If treated with epoetin: patients with a stable hematocrit ≤ 40% (± 5%).

Exclusion Criteria:

  • Inability to discontinue angiotensin II receptor blockers (ARBs) safely for a period of 1 week, as required by the protocol.
  • Treatment with more than 3 different compounds for the treatment of hypertension at Visit 1.
  • Atrial fibrillation

Other protocol-defined exclusion criteria may apply.

Both
18 Years to 80 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany,   Switzerland
 
NCT00171080
CVAL489ADE19
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP