- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01095822
Effects of Valsartan and Aliskiren on Hemostatic Indices in Hypertensive Diabetics
A Randomized Evaluation of the Effects of Valsartan and Aliskiren in Combination Versus Tekturna Alone on Hemostatic Biomarkers in Patients With Newly Diagnosed Mild to Moderate Hypertension and Type 2 Diabetes Mellitus
Study Overview
Detailed Description
Objectives:
There are 2 objectives in the index study. • The primary objective is to determine how therapy with valsartan (160mg/daily) in combination with aliskiren (150-300mg/daily) over four weeks affects platelet/coagulation/fibrinolytic biomarkers in recently diagnosed hypertensive patients with type 2 diabetes mellitus. However, this is an exploratory study, our current knowledge is based on in vitro and ex vivo evidence for valsartan, but only on in vitro aliskiren data. There are no data on antithrombotic biomarkers currently available for the combination therapy.
The secondary objective is:
• To define whether combination therapy is superior over monotherapy with aliskiren with regard to the improvement of hemostatic biomarkers (platelet aggregation, expression of GP IIb/IIIa, and plasma levels of antithrombin-III).
Study Design:
This is a randomized 1:1, two arm, single-blind, single-site, parallel group, post-marketing comparison study of the effects on antithrombotic biomarkers of aliskiren 150-300mg/day alone vs combined treatment with aliskiren 150-300mg/day plus valsartan 160mg/day over a four week primary treatment period. An optional four week extension phase may be offered pending assessment of the antithrombotic biomarker assays at week four.
Population:
Two groups (25 patients each), for a total of 50, recently diagnosed hypertensive patients with previously diagnosed mild to moderate type 2 diabetes will constitute the proposed study population. The diagnosis of diabetes will be made based on the American Diabetes Association criteria, such as random plasma glucose >200 mg/dL with or without symptoms of hyperglycemia (polydipsia, polyuria, polyphagia) and weight loss, or fasting plasma glucose > 126 mg/dL, to be determined at least twice. Patients will qualify if they are insulin-free, treated with an oral antiglycemic agent,(metformin only) and/or managed on diet alone for no less than 30 days and have adequate glucose control at the time of their Screening Visit.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21215
- Dr. Pokov's Polyclinic. 6821 Reisterstown Road Suite 206
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
The diagnosis of Type 2 Diabetes Mellitus will have been determined by the following Criteria, as characterized by recurrent or persistent hyperglycemia, and diagnosed by demonstrating any one of the following.
- Fasting plasma glucose level at or above 126 mg/dL but less than 250 mg/dL on more than one determination.
- Plasma glucose at or above 200 mg/dL two hours after a 75 g oral glucose load as in a glucose tolerance test.
- Symptoms of hyperglycemia and casual plasma glucose at or above 200 mg/dL.
- Glycated hemoglobin (hemoglobin A1C) at or above 6.5 but below 8.5%. (This criterion was recommended by the American Diabetes Association in 2010).
- Adults between 21 - 65 years old
- Have been diagnosed with Type 2 DM according to the criteria listed above, and treated with metformin 1-2 g/daily as their only diabetic medication, and/or an approved ADA diet for no less than 30 days.
Documented evidence of Stage 1 or Stage 2 essential hypertension as noted below: However, the actual treatment threshold will be left to the discretion of the study investigators.
Stage 1: systolic 140-159 mmHg and diastolic 90-99 mmHg Stage 2: systolic >160 mmHg and diastolic >100 mmHg However, there is accumulated evidence that patients with consistent blood pressures over 130/80 mmHg along with Type 1 or Type 2 diabetes, or kidney disease are at increased risk for progressive morbidity and mortality and require a lower threshold for further treatment.
- Aspirin 81 mg/daily
- Signed informed consent
- Must maintain same diet/exercise regimen
Exclusion Criteria:
- Thrombolytic therapy, GP IIb/IIIa inhibitor, thienopyridines, antifibrinolytics, COX- inhibitors, prostacyclin analogues, and vitamin K antagonists within 30 days of enrollment
- Platelet count < 100,000/microL
- History of bleeding disorder
- Hct < 30%, serum creatinine ≥3 mg/dL, liver impairment defined as ALT/AST > 3 times upper limit of normal.
- Glomerular filtration rate <60ml/min/1.73m2
- Patients currently treated with any antiplatelet agent other than aspirin 81 mg/day
- Admission for acute vascular syndrome (unstable angina, MI, stroke), revascularization procedure with stent placement, or other major coronary/cerebrovascular event within 30 days.
- Active participation in other investigational drug or device trial within the last 30 days.
- Allergy or intolerance to any of the study medications.
- Congestive Heart Failure (NYHA I-IV)
- Malignancies except treated non-melanoma superficial skin cancers
- Acute infections
- Type I diabetes, Cushings syndrome, or pancreatic deficiency due to malignancy or systemic disease
- Insulin therapy, sulfonylureas, thiazolidinediones,meglitinides, D-phenylalanine derivatives, amylin synthetic derivatives, and incretin mimetics.
- Pregnancy, confirmed by serum rosette inhibition assay for early pregnancy factor detectable. For women of child-bearing potential (WOCP), continuous abstinence, fertility awareness, hormonal contraceptives, and/or mechanical methods will apply to prevent pregnancy during the entire study duration. Should a subject become pregnant during the study, the anti-hypertensive treatment with either or both study medications will be discontinued immediately by the treating physician/investigator as per FDA warnings regarding potential fetal/neonatal morbidity and mortality.
- Age over 65 years
- History of cigarette smoking within past 10 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aliskiren
25 patients with recently diagnosed hypertension and mild to moderate type 2 diabetes will constitute the proposed study population.
The diagnosis of diabetes will be made based on the American Diabetes Association criteria, such as random plasma glucose >200 mg/dL with or without symptoms of hyperglycemia (polydipsia, polyuria, polyphagia) and weight loss, or fasting plasma glucose > 126 mg/dL, to be determined at least twice.
Patients will qualify if they are insulin-free, treated with an oral antiglycemic agent,(metformin only) and/or managed on diet alone for no less than 30 days and have adequate glucose control at the time of their Screening Visit.
|
Comparison of combination (aliskiren + valsartan) therapy versus valsartan alone on hemostatic indices
|
Experimental: Aliskiren + Valsartan
25 patients with recently diagnosed hypertension, and mild to moderate type 2 diabetes will constitute the proposed study population.
The diagnosis of diabetes will be made based on the American Diabetes Association criteria, such as random plasma glucose >200 mg/dL with or without symptoms of hyperglycemia (polydipsia, polyuria, polyphagia) and weight loss, or fasting plasma glucose > 126 mg/dL, to be determined at least twice.
Patients will qualify if they are insulin-free, treated with an oral antiglycemic agent,(metformin only) and/or managed on diet alone for no less than 30 days and have adequate glucose control at the time of their Screening Visit.
|
Comparison of combination (aliskiren + valsartan) therapy versus valsartan alone on hemostatic indices
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
How therapy with valsartan (160mg/daily) in combination with aliskiren (150-300mg/daily) affects platelet/coagulation/fibrinolytic biomarkers in recently diagnosed hypertensive patients with type 2 diabetes mellitus.
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Whether combination therapy is superior over monotherapy with aliskiren with regard to the improvement of hemostatic biomarkers (platelet aggregation, expression of GP IIb/IIIa, and plasma levels of antithrombin-III).
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Victor Serebruany, MD, PhD, HeartDrug Research LLC
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DT-NOV-09-37918
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
Meir Medical CenterCompletedDiabetes Mellitus Type 2 | Diabetes Mellitus, Non-insulin Dependant | Diabetes Mellitus, on Oral Hypoglycemic Treatment | Adult Type Diabetes MellitusIsrael
-
Medical College of WisconsinMedical University of South CarolinaCompletedDiabetes Mellitus | Type 2 Diabetes Mellitus | Adult-Onset Diabetes Mellitus | Non-Insulin-Dependent Diabetes Mellitus | Noninsulin Dependent Diabetes Mellitus, Type IIUnited States
-
Hanmi Pharmaceutical Company LimitedUnknownType2 Diabetes Mellitus | Type1 Diabetes MellitusUnited States
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Joslin Diabetes CenterCambridge Medical Technologies, LLCCompletedType 2 Diabetes Mellitus | Type1 Diabetes MellitusUnited States
-
Medical College of WisconsinMedical University of South Carolina; National Institute of Diabetes and Digestive...Active, not recruitingDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
-
Medical College of WisconsinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
Clinical Trials on Aliskiren + Valsartan
-
NovartisThe TIMI Study GroupCompletedMyocardial Ischemia | Post Acute Coronary SyndromeGermany, Spain, United States, Belgium, Canada, Czech Republic, Hungary, Netherlands, Poland, Russian Federation, Sweden
-
NovartisCompletedHypertensionSingapore, Hungary, Czech Republic, United Kingdom
-
NovartisCompleted
-
NovartisCompleted
-
NovartisCompletedHypertensionSlovakia, Italy, Netherlands, Argentina, Germany, Poland, Czech Republic, Iceland
-
Brigham and Women's HospitalTerminatedInsulin Sensitivity | Diastolic Function | Aortic ComplianceUnited States
-
NovartisCompletedEssential HypertensionGermany, Spain, United States
-
NovartisCompleted
-
Novartis PharmaceuticalsCompletedHypertensionUnited States, Belgium, Hungary, Turkey, Guatemala, Slovakia, Germany, Puerto Rico, Poland
-
NovartisCompleted