Diabetic NephropathiesPhase 4NCT00153023
1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy
A Phase 4 study testing Telmisartan and Valsartan in people with Diabetic Nephropathies and Hypertension, run by Boehringer Ingelheim at 111 sites in 13 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetic Nephropathies, Hypertension
- What is being tested?
- Telmisartan and Valsartan
- How many people
- 885 participants
- Where
- 111 sitesin 13 countries
- Study dates
- Apr 2003to Dec 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Aged 30-70 years of age
- 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)
- Overt nephropathy defined by 24 hour proteinuria >= 900 mg and by serum creatinine below 265 mol/l (3.0 mg/dl)
Who cannot join
None listed.
Trial locations and contacts
111 sites in 13 countries.
111 sites in 13 countries
Germany18 sites
Boehringer Ingelheim Investigational Site
Aschaffenburg, 63739
Diabetes Klinik Bad Mergentheim
Bad Mergentheim, 97980
Institut fur Klinische Forschung
Berlin, 10115
Charite Campus Buch
Berlin, 13125
KFH Dialysezentrum
Eberswalde, 16225
Universitatsklinik Heidelberg
Heidelberg, 69115
Boehringer Ingelheim Investigational Site
Karlsruhe, 76133
Institut fur Klinische Forschung
Mainz, 55116
Boehringer Ingelheim Investigational Site
Münster, 48145
Boehringer Ingelheim Investigational Site
Neuwied, 56564
Boehringer Ingelheim Investigational Site
Pirna, 01796
Boehringer Ingelheim Investigational Site
Riesa, 01587
Boehringer Ingelheim Investigational Site
Rosenheim, 83022
Boehringer Ingelheim Investigational Site
Saarbrücken, 66121
Boehringer Ingelheim Investigational Site
Saarlouis, 66740
Boehringer Ingelheim Investigational Site
Sinsheim, 74889
Boehringer Ingelheim Investigational Site
Speyer, 67346
Internist
Würzburg, 97072
Russia12 sites
Medical Academy named Sechenova I.M.
Moscow, 103030
Russian State Medical University
Moscow, 107066
Russian State Medical University
Moscow, 115516
National Endocrinology Research Center of Russia
Moscow, 117036
Russian State Medical University
Moscow, 117485
President's Medical Center
Moscow, 121356
Russian Cardiology Research Center
Moscow, 121552
Russian Academy for Advanced Medical Studies
Moscow, 125315
Moscow President's Medical Center
Moscow, 129090
Regional Clinical Scientific Research Institute
Moscow, 129110
City Hospital of Saint Elizaveta
Saint Petersburg, 195257
Military Medical Academy
Saint Petersburg, 198013
France11 sites
Chu Sud
Amiens, 80054
Centre Hospitalier
Beauvais, 60021
Hopital Duchenne
Boulogne-sur-Mer, 62320
Hopital Clemenceau
Caen, 14033
Centre Hospitalier
Dunkirk, 59240
Hopital Albert Michalon
La Tronche, 38700
Hopital A.Mignot
Le Chesnay, 78157
Hopital Maison Blanche
Reims, 51100
Hopital Yves Le Foll
Saint-Brieuc, 22023
Hopital Saint Quentin
Saint-Quentin, 02100
Centre Hospitalier
Valenciennes, 59322
Italy10 sites
Azienda Ospedaliera Policlinico S. Orsola Malpighi
Bologna, 40138
Ospedali Riuniti di Livorno
Livorno, 57100
Presidio Ospedaliero Campo di Marte
Lucca, 55100
Universita degli Studi "Federico II"
Naples, 80131
Azienda Ospedaliera di Padova
Padova, 35128
IRCCS Policlinico S.Matteo
Pavia, 27100
Policlinico Monteluce
Perugia, 06100
Azienda Ospedaliera S. Maria degli Angeli
Pordenone, 33170
Ospedale "S. Maria delle Croci"
Ravenna, 48100
Universita Tor Vergata
Roma, 00133
Slovakia10 sites
NovaMed
Banská Bystrica, 974 05
Ministry Hospital of Internal Affairs
Bratislava, 812 72
Faculty Hospital
Bratislava, 81369
Faculty Hospital of L. Derer
Bratislava, 833 05
Diabetologic and Internal Clinic
Lučenec, 984 01
Faculty Hospital
Nitra, 94901
Hospital Nove Mesto
Nové Mesto, 915 01
Regional Hospital Nove Zamky
Nové Zámky, 940 52
MSP-DIAGNOSTIK, Ltd.
Trenčín, 91101
Faculty Hospital Trnava
Trnava, 91701
Portugal9 sites
Centro Hospitalar de Coimbra
Coimbra, 3041.853
Hospital Distrital de Faro
Faro, 8000-386
Hospital Curry Cabral
Lisbon, 1050-035
Hospital de Santa Maria
Lisbon, 1169-024
Hospital de Santa Marta
Lisbon, 1169-024
Associac?o Protectora dos Diabeticos de Portugal
Lisbon, 1250
Hospital Pedro Hispano
Matosinhos Municipality, 4460-301
Hospital de S. Jo?o
Porto, 4200
Centro Hospitalar Vila Nova de Gaia
Vila Nova de Gaia, 4434-502
Spain9 sites
Hospital Torrecardenas
Almería, 04009
Hospital Ntra. Sra de Sonsoles
Ávila, 05071
Hospital Clinico y Provincial de Barcelona
Barcelona, 08036
Hospital Vall d'Hebron
Barcelona, 08038
Hospital de Basurto
Bilbao, 48013
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital de Cabuenes
Gijón, 33204
Hospital Virgen del Rocio
Seville, 41013
Hospital Universitario La Fe
Valencia, 46009
Czechia7 sites
University Hospital St. Anna
Brno, 656 91
University Hospital Hradec Kralove
Hradec Králové, 500 05
University Hospital Vihohrady
Prague, 100 34
General University Hospital
Prague, 128 08
District Hospital Tabor
Tábor, 390 03
Masaryk Hospital
Ústí nad Labem, 401 13
Hospital Usti nad Orlici
Ústí nad Orlicí, 562 18
Ukraine7 sites
Dnyepropyetrovsk Medical Academy
Dnyepropetrovsk, 49044
Kharkiv Medical State University
Kharkiv, 61022
Institute of Diabetic pathology problems
Kharkiv, 61070
Institute of Cardiology
Kiev, 03151
V.P. Komisarenko Institute of Endocrinology and Metabolism
Kiev, 04114
Kyiv Clinical Hospital No. 1
Kyiv, 02091
Zaporozhye Regional Clinical Hospital
Zaporizhzhya, 69600
Malaysia6 sites
Penang General Hospital
George Town
Hospital Ipoh
Ipoh, Perak, 30990
University Sains Malaysia
Kelantan, 16150
Hospital Kuala Lumpur
Kuala Lumpur, 50586
University Malaya Medical Centre
Kuala Lumpur, 59100
Hospital Putrajaya
Kuala Selangor
Denmark5 sites
Medical Department
Copenhagen NV, DK-2400
Medicinsk afdeling
Fredericia, DK-7000
Medicinsk afdeling F, Endokrinologisk
Hiller?d, 3400
Endokrinologisk afdeling
Hvidovre, DK-2650
Medical Department
Roskilde, DK-4000
Taiwan5 sites
Changhua Christian Hospital
Changhua, 500
Chi Mei Medical Center
Dawan, 701
Buddhist Tzu Chi Hospital
Hualien City, 970
National Cheng Kung University Hospital
Tainan, 70428
Mackay Memorial Hospital
Taipei, 104
South Korea2 sites
Keimyung University Dongsan Medical Center
Daegu, 700712
Yonsei University Medical Center
Seoul
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Nephropathies, Hypertension
- Being tested
- Telmisartan, Valsartan
- Medical subject headings
- Diabetic Nephropathies, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
ValsartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (Visit 6) in 24 hour proteinuria, after one year of treatment (study end) with telmisartan 80 mg versus valsartan 160 mg.
Measured: Baseline, after 1 year of treatment
Secondary outcomes (13)
Change from baseline in 24-hour urinary albumin excretion rate (UAER).
Measured: Baseline, after 1 year of treatment
Change from baseline in 24-hour urinary sodium excretion rate.
Measured: Baseline, after 1 year of treatment
Change from baseline in serum creatinine.
Measured: Baseline, after 1 year of treatment
Change from baseline in creatinine clearance
Measured: Baseline, after 1 year of treatment
Change from baseline in estimated glomerular filtration rate (eGFR).
Measured: Baseline, after 1 year of treatment
Change from baseline in plasma asymmetrical dimethylarginine (ADMA) levels.
Measured: Baseline, after 1 year of treatment
Change from baseline in urine 8-iso-prostaglandin F2α levels
Measured: Baseline, after 1 year of treatment
Change from baseline in serum high sensitive C-reactive protein (CRP) levels.
Measured: 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
Measured: 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).
Measured: after 1 year of treatment
Change from baseline in insulin sensitivity (Homeostasis Model Assessment (HOMA) index).
Measured: Baseline, after 1 year of treatment
Change from baseline in plasma adiponectin levels.
Measured: Baseline, after 1 year of treatment
Change from baseline in BP endpoints (SBP, DBP and pulse pressure)
Measured: Baseline, after 1 year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 885 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. Pharma GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153023
- Sponsor's protocol ID
- 502.396
- Status last verified
- Nov 2013
- First submitted
- 9 Sep 2005
- Last updated
- 13 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00153023
- Acronym / sponsor ID
- 502.396
- Conditions
- Diabetic Nephropathies, Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 885 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes mellitus
- Aged 30-70 years of age
- Hypertension at screening defined as:
- Overt nephropathy defined by 24 hour proteinuria >= 900 mg and by serum creatinine below 265 mol/l (3.0 mg/dl)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telmisartan | Drug | – |
| Valsartan | Drug | – |
Primary outcome
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
13 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Related InfoLink provided by the sponsor.
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Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
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Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
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A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
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Relationship Between Insulin Dose and Complications in Type 1 Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator study chair
B.I. Pharma GmbH & Co. KG
111 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telmisartan and Valsartan in people with Diabetic Nephropathies and Hypertension, run by Boehringer Ingelheim at 111 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 111 sites in Germany, Russia, France, Italy, Slovakia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.