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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

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ClinicalTrials.gov Identifier: NCT00171080
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Hypertension Drug: valsartan Drug: irbesartan Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis




Primary Outcome Measures :
  1. Change from baseline in systolic blood pressure after 4 weeks

Secondary Outcome Measures :
  1. Change from baseline in diastolic blood pressure after 4 weeks
  2. Systolic blood pressure less than 100 mmHg with or without symptoms of low blood pressure
  3. Adverse events and clinical laboratory abnormal results
  4. Change from baseline in average 24-hour ambulatory blood pressure after 4 weeks
  5. Change from baseline in daytime and nighttime ambulatory blood pressures after 4 weeks


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171080


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

Additional Information:
Publications of Results:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171080     History of Changes
Other Study ID Numbers: CVAL489ADE19
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017

Keywords provided by Novartis:
Hypertension
Valsartan
Dialysis
Renal Disease

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Irbesartan
Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action