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1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00153023
First Posted: September 12, 2005
Last Update Posted: November 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  Purpose

The general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood pressure beyond the target of 130/80 mmHg after one year of treatment.

The primary objective of this study is to show that telmisartan 80 mg is at least as effective (i.e., not inferior) and possibly superior to valsartan 160 mg in reducing 24 hour proteinuria after one year of treatment.


Condition Intervention Phase
Diabetic Nephropathies Hypertension Drug: Telmisartan Drug: Valsartan Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Investigate the Efficacy of Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy VIVALDI-Study

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change from baseline (Visit 6) in 24 hour proteinuria, after one year of treatment (study end) with telmisartan 80 mg versus valsartan 160 mg. [ Time Frame: Baseline, after 1 year of treatment ]

Secondary Outcome Measures:
  • Change from baseline in 24-hour urinary albumin excretion rate (UAER). [ Time Frame: Baseline, after 1 year of treatment ]
  • Change from baseline in 24-hour urinary sodium excretion rate. [ Time Frame: Baseline, after 1 year of treatment ]
  • Change from baseline in serum creatinine. [ Time Frame: Baseline, after 1 year of treatment ]
  • Change from baseline in creatinine clearance [ Time Frame: Baseline, after 1 year of treatment ]
  • Change from baseline in estimated glomerular filtration rate (eGFR). [ Time Frame: Baseline, after 1 year of treatment ]
  • Change from baseline in plasma asymmetrical dimethylarginine (ADMA) levels. [ Time Frame: Baseline, after 1 year of treatment ]
  • Change from baseline in urine 8-iso-prostaglandin F2α levels [ Time Frame: Baseline, after 1 year of treatment ]
  • Change from baseline in serum high sensitive C-reactive protein (CRP) levels. [ Time Frame: Baseline, after 1 year of treatment ]
  • Time to a composite of a doubling of serum creatinine concentration , end-stage renal disease (ESRD), or all cause death [ Time Frame: after 1 year of treatment ]
  • Time to a composite of morbidity and mortality from cardiovascular causes (myocardial infarction (MI), stroke, first hospitalisation for heart failure or unstable angina, coronary or peripheral revascularisation). [ Time Frame: after 1 year of treatment ]
  • Change from baseline in insulin sensitivity (Homeostasis Model Assessment (HOMA) index). [ Time Frame: Baseline, after 1 year of treatment ]
  • Change from baseline in plasma adiponectin levels. [ Time Frame: Baseline, after 1 year of treatment ]
  • Change from baseline in BP endpoints (SBP, DBP and pulse pressure) [ Time Frame: Baseline, after 1 year of treatment ]

Estimated Enrollment: 885
Study Start Date: April 2003
Estimated Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Detailed Description:

This is a randomised, double-blind, double-dummy, forced titration, multicentre, parallel group trial in patients with essential hypertension, diabetes mellitus type 2 and diabetic nephropathy.

After a 4-6 week Run-in period, patients are randomised to one of the treatment groups and receive either Telmisartan 40 - 80 mg or Valsartan 80 - 160 mg. The treatment regimen is a forced titration with the lower dose given for 2 weeks and the higher dose given for the rest of the treatment period summing up to 52 weeks of treatment. During the treatment period, 8 visits to the investigator are scheduled in order to control blood pressure, renal function parameters and safety. In addition, parameters of endothelial function and oxidative stress are measured at baseline, 6 months and after one year of treatment.

Study Hypothesis:

Non-inferiority of telmisartan 80 mg compared to valsartan 160 mg will be tested using the following set of hypotheses:

Null Hypothesis:

The overall mean change from baseline in UPER (24 hour urinary protein excretion rate) for telmisartan 80 mg is inferior to that for valsartan 160 mg by 0.5 g/day or more.

Alternative Hypothesis:

The overall mean change from baseline in UPER (24 hour urinary protein excretion rate) for telmisartan 80 mg is less than 0.5 g/day worse than that for valsartan 160 mg.

Comparison(s):

In order to test the non-inferiority hypothesis, analysis of covariance with treatment and centre as main effects and baseline as a covariate will be performed. Time-to-event data will be analysed using the log-rank test.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type 2 diabetes mellitus
  2. Aged 30-70 years of age
  3. Hypertension at screening defined as:

    • an average cuff systolic blood pressure > 130 mmHg and/or diastolic blood pressure >80 mmHg in untreated patients OR
    • patients receiving antihypertensive therapy (i.e., medications specifically prescribed to treat hypertension)
  4. Overt nephropathy defined by 24 hour proteinuria >= 900 mg and by serum creatinine below 265 mol/l (3.0 mg/dl)

Exclusion Criteria: None

  Contacts and Locations
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): NCT00153023


  Show 111 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Pharma GmbH & Co. KG
  More Information

ClinicalTrials.gov Identifier: NCT00153023     History of Changes
Other Study ID Numbers: 502.396
First Submitted: September 9, 2005
First Posted: September 12, 2005
Last Update Posted: November 13, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Telmisartan
Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action