HypertensionPhase 4NCT00982358
Anti-Inflammatory Actions of Valsartan in Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing Valsartan in people with Hypertension and Type 2 Diabetes Mellitus, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
This study is designed to support the use of valsartan in the diabetic population. Two different groups will be studied, one with and one without coronary artery disease (CAD) documented by angiography. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hypertension, Type 2 Diabetes Mellitus, Coronary Artery Disease
- What is being tested?
- Valsartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2004to Mar 2007
- 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
- Adult, Older adult
Who may be able to join
- Male or female patients between 30 and 80 years old, inclusive
- Controlled type 2 Diabetes Mellitus on stable treatment at least during the 4 weeks prior to visit 1
- Treated or untreated stage 1 (according to JNC VII Guidelines) or grade 1 (according to ESH/ESC 2003 Guidelines) hypertensive patients
- For one stratum: angiographically proven CAD
- Signed informed consent prior to any study procedure
Who cannot join
- Hypertension classified as stage 2 (or grade 2) or higher
- Normotensive patients, i.e. patients who do not have a history of high blood pressure, and who are not receiving any antihypertensive medication
- Treatment with more than 2 antihypertensive medications
- Current treatment with ARBs
- Glycated hemoglobin (HbA1c) >8.5% at Visit 1
- Current treatment with glitazones
Show all 30Show fewer
- Myocardial infarction less than 3 months prior to Visit 1
- Total cholesterol >7.8 mmol/l
- Past diagnosis of any systemic inflammatory disease
- Known or suspected contraindications, including history of allergy to angiotensin receptor blockers
- History of hypertensive encephalopathy or cerebrovascular accident less than 1 year prior to Visit 1
- Known Keith-Wagener grade III or IV hypertensive retinopathy
- History of heart failure
- Second or third degree heart block without a pacemaker
- Concomitant unstable angina pectoris
- Concurrent potential life threatening arrhythmia or symptomatic arrhythmia
- Clinically significant valvular heart disease
- Evidence of hepatic disease as determined by any one of the following: ALT or AST values > 2 x ULN at Visit 1, a history hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
- Evidence of renal impairment as determined by any one of the following: serum creatinine >1.25 x ULN at visit 1, a history of dialysis, or a history of nephritic syndrome
- Sodium value <132 mmol/L at Visit 1
- Serum potassium values <3.5 mmol/L or >5.5 mmol/L at visit 1
- Any surgical or medical condition which might alter the absorption, distribution, metabolism, excretion of any drug
- Female patients who are not either post-menopausal for one year of surgically sterile, and who are not using effective contraceptive methods such as barrier method with spermicidal or an intra-uterine device. Oral contraceptive use or dermal implants as the only means of contraception are disallowed
- Pregnant or lactating females
- Any surgical or medical condition which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patients from complying with the requirements of the study or completing the trial period
- History of malignancy including leukemia and lymphoma within 5 years prior to Visit 1
- History of any severe, life threatening disease within the past five years
- Any previous history of a systemic autoimmune disease
- History of drug or alcohol abuse within the last two years
- Participation in any investigational drug trial within one month prior to visit 1
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité University Medicine Berlin, Center for Cardiovascular Research, Outpatient Clinic
Berlin, State of Berlin, 10115
University of Ulm, Department of Internal Medicine II
Ulm, Baden-Wurttemberg, 89081
About this study
Official title: A 16-weeks, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Anti-inflammatory Actions of 320 mg Diovan in Patients With Type 2 Diabetes With and Without Coronary Artery Disease
This study is designed to support the use of valsartan in the diabetic population. Two different groups will be studied, one with and one without coronary artery disease (CAD) documented by angiography.
The study is intended to demonstrate that valsartan 320 mg has an anti-inflammatory potential, reducing inflammatory serum markers as well as inflammatory gene expression, and to show that valsartan is able to improve metabolic parameters in this patient population. Furthermore, in the subgroup of patients with documented CAD this study wants to show that valsartan improves coronary perfusion.
Read more
3 Objectives
Primary objectives:
- To demonstrate the anti-inflammatory efficacy of valsartan 160/320 mg by testing the hypothesis of superiority compared to placebo in the reduction of the inflammatory marker Tumor necrosis factor alpha (TNFα) in plasma after 16 weeks of treatment in hypertensive patients with type 2 diabetes mellitus.
- To demonstrate the anti-inflammatory efficacy of valsartan 160/320 mg by testing the hypothesis of superiority compared to placebo in the reduction of the inflammatory marker Interleukin 6 (IL-6) in plasma after 16 weeks of treatment in hypertensive patients with type 2 diabetes mellitus.
Secondary objectives:
- To explore the effect of 160/320 mg valsartan on parameters of insulin sensitivity.
- To explore the effect of 160/320 mg valsartan on additional inflammatory markers in plasma [e.g. C-Reactive protein (CRP), soluble intracellular adhesion molecule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), serum amyloid A (SAA), soluble CD40 ligand (sCD40L), fibrinogen, Interleukin 1β (IL-1β), matrix metalloproteases -2, -3 and -9 (MMP-2, -3, -9), and sE-selectin)].
- To explore the effect of 160/320 mg valsartan on inflammatory gene expression from monocytes and fat tissue.
- To explore the effect of 160/320 mg valsartan on metabolic gene expression in fat tissue.
- To explore the effect of 160/320 mg valsartan on coronary perfusion, in the group of patients with angiographically documented CAD.
- Being tested
- Valsartan, Placebo
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Valsartan | Active comparator | Not described Receives: Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study was to evaluate the anti-inflammatory effect of VAL by analyzing the reduction of the inflammatory markers interleukin-6 (IL-6) and tumor necrosis factor alpha (TNFα) in serum after 16 weeks of treatment.
Secondary outcomes (5)
To explore the effect of 160/320 mg valsartan on parameters of insulin sensitivity.
To explore the effect of 160/320 mg valsartan on additional inflammatory markers in plasma
To explore the effect of 160/320 mg valsartan on inflammatory gene expression from monocytes and fat tissue
To explore the effect of 160/320 mg valsartan on metabolic gene expression in fat tissue.
To explore the effect of 160/320 mg valsartan on coronary perfusion, in the group of patients with angiographically documented CAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startJul 2004
- Primary completionOct 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- 121 participants
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982358
- Sponsor's protocol ID
- CVAL489A2423
- Other IDs
- Ek#2140
- Status last verified
- Sep 2009
- First submitted
- 22 Sep 2009
- Last updated
- 23 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16-weeks, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Anti-inflammatory Actions of 320 mg Diovan in Patients With Type 2 Diabetes With and Without Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00982358
- Acronym / sponsor ID
- CVAL489A2423
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University of Ulm
- Study start
- Jul 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 23 Sep 2009 (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.
This study is designed to support the use of valsartan in the diabetic population. Two different groups will be studied, one with and one without coronary artery disease (CAD) documented by angiography.
The study is intended to demonstrate that valsartan 320 mg has an anti-inflammatory potential, reducing inflammatory serum markers as well as inflammatory gene expression, and to show that valsartan is able to improve metabolic parameters in this patient population. Furthermore, in the subgroup of patients with documented CAD this study wants to show that valsartan improves coronary perfusion.
3 Objectives
Primary objectives:
- To demonstrate the anti-inflammatory efficacy of valsartan 160/320 mg by testing the hypothesis of superiority compared to placebo in the reduction of the inflammatory marker Tumor necrosis factor alpha (TNFα) in plasma after 16 weeks of treatment in hypertensive patients with type 2 diabetes mellitus.
- To demonstrate the anti-inflammatory efficacy of valsartan 160/320 mg by testing the hypothesis of superiority compared to placebo in the reduction of the inflammatory marker Interleukin 6 (IL-6) in plasma after 16 weeks of treatment in hypertensive patients with type 2 diabetes mellitus.
Secondary objectives:
- To explore the effect of 160/320 mg valsartan on parameters of insulin sensitivity.
- To explore the effect of 160/320 mg valsartan on additional inflammatory markers in plasma [e.g. C-Reactive protein (CRP), soluble intracellular adhesion molecule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), serum amyloid A (SAA), soluble CD40 ligand (sCD40L), fibrinogen, Interleukin 1β (IL-1β), matrix metalloproteases -2, -3 and -9 (MMP-2, -3, -9), and sE-selectin)].
- To explore the effect of 160/320 mg valsartan on inflammatory gene expression from monocytes and fat tissue.
- To explore the effect of 160/320 mg valsartan on metabolic gene expression in fat tissue.
- To explore the effect of 160/320 mg valsartan on coronary perfusion, in the group of patients with angiographically documented CAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| Valsartan | Active comparator | Drug: Valsartan |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients between 30 and 80 years old, inclusive
- Controlled type 2 Diabetes Mellitus on stable treatment at least during the 4 weeks prior to visit 1
- Treated or untreated stage 1 (according to JNC VII Guidelines) or grade 1 (according to ESH/ESC 2003 Guidelines) hypertensive patients
- For one stratum: angiographically proven CAD
- Signed informed consent prior to any study procedure
Key exclusion criteria (30 listed)
- Hypertension classified as stage 2 (or grade 2) or higher
- Normotensive patients, i.e. patients who do not have a history of high blood pressure, and who are not receiving any antihypertensive medication
- Treatment with more than 2 antihypertensive medications
- Current treatment with ARBs
- Glycated hemoglobin (HbA1c) >8.5% at Visit 1
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 |
|---|---|---|
| Valsartan | Drug | Valsartan |
| Placebo | Other | Placebo |
Primary outcome
The primary objective of the study was to evaluate the anti-inflammatory effect of VAL by analyzing the reduction of the inflammatory markers interleukin-6 (IL-6) and tumor necrosis factor alpha (TNFα) in serum after 16 weeks of treatment.
5 secondary outcomes
To explore the effect of 160/320 mg valsartan on parameters of insulin sensitivity.
To explore the effect of 160/320 mg valsartan on additional inflammatory markers in plasma
To explore the effect of 160/320 mg valsartan on inflammatory gene expression from monocytes and fat tissue
To explore the effect of 160/320 mg valsartan on metabolic gene expression in fat tissue.
To explore the effect of 160/320 mg valsartan on coronary perfusion, in the group of patients with angiographically documented CAD
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 23 Sep 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valsartan in people with Hypertension and Type 2 Diabetes Mellitus, run by Charite University, Berlin, Germany at 2 sites in Germany.
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 5 inclusion and 30 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 23 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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. Some participants in this study may receive a placebo. 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?
The primary objective of the study was to evaluate the anti-inflammatory effect of VAL by analyzing the reduction of the inflammatory markers interleukin-6 (IL-6) and tumor necrosis factor alpha (TNFα) in serum after 16 weeks 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 23 Sep 2009.