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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


Phase 4
30 Years
80 Years
Not Enrolling
Both
Hypertension, Type 2 Diabetes Mellitus, Coronary Artery Disease

Thank you

Trial Information

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


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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 (TNF╬▒) in serum after 16 weeks of treatment.

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CVAL489A2423

NCT ID:

NCT00982358

Start Date:

July 2004

Completion Date:

March 2007

Related Keywords:

  • Hypertension
  • Type 2 Diabetes Mellitus
  • Coronary Artery Disease
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Coronary Disease
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Hypertension

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