Double Blind Placebo Study of Vildagliptin in Prehypertensives Type II Diabetics (Prediab) (PREDIAB)
This study is not yet open for participant recruitment.
Verified October 2009 by Aristotle University Of Thessaloniki
Sponsor:
Aristotle University Of Thessaloniki
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01001962
First received: October 26, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
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Purpose
Primary
- Reduction of 24h BP in type II diabetics with prehypertension in subjects receiving VILDAGLIPTIN
- Primary prevention of new onset of hypertension in subjects receiving VILDAGLIPTIN
Secondary
- Reduction of non dipping status, day and nighttime BP, morning BP surge in subjects receiving VILDAGLIPTIN
- Reduction in the total cardiovascular risk in subjects receiving VILDAGLIPTIN.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Type 2 Diabetes |
Drug: Metformin Drug: VILDAGLIPTIN |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double Blind Placebo Study of Vildagliptin in Prehypertensives Type II Diabetics |
Resource links provided by NLM:
Further study details as provided by Aristotle University Of Thessaloniki:
Primary Outcome Measures:
- Reduction of 24h BP in type II diabetics with prehypertension [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Primary prevention of new onset of hypertension [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 125 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Metformin
Treat with Metformin for type II diabetes for 4 weeks and then add placebo drug
|
Drug: Metformin
Treat with Metformin for type II diabetes for 4 weeks and then add placebo. Collected data: 24h SBP and DBP in time 0, 4, 12, 24 week.
|
|
Active Comparator: VILDAGLIPTIN
Treat with Metformin for type II diabetes for 4 weeks and then add VILDAGLIPTIN.
|
Drug: VILDAGLIPTIN
Treat with Metformin for type II diabetes for 4 weeks and then add VILDAGLIPTIN. Collected data: 24h SBP and DBP in time 0, 4, 12, 24 week.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age between 18 and 60 years.
- All patients are going to give their informed consent to participate in the study.
- Patients who are not receiving antihypertensive or diabetes treatment
- BP between 120 to 130 mmHg for systolic BP (prehypertensives)
- Type II diabetes (HbA1c 6.5-7.5)
Exclusion Criteria:
- Known oversensitiveness
- Chronic renal disease (GFR<50 ml/min) or ESRD
- Heart or respiratory failure
- Recent MI
- Shock
- Liver deficiency (ALT or AST >3 times normal
- Chronic alcohol use and pregnancy or lactation.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001962
Contacts
| Contact: VASILEIOS KOTSIS, PROF | +306974748860 | vkotsis@auth.gr |
Locations
| Greece | |
| Hypertension 24h ABPM center Papageorgiou Hospital | Not yet recruiting |
| Thessaloniki, Greece | |
| Contact: VASILEIOS KOTSIS, PROF | |
| Principal Investigator: VASILEIOS KOTSIS, PROF | |
Sponsors and Collaborators
Aristotle University Of Thessaloniki
More Information
No publications provided
| Responsible Party: | KOTSIS VASILEIOS, AUTH |
| ClinicalTrials.gov Identifier: | NCT01001962 History of Changes |
| Other Study ID Numbers: | PREDIAB |
| Study First Received: | October 26, 2009 |
| Last Updated: | October 26, 2009 |
| Health Authority: | Greece: Ethics Committee |
Keywords provided by Aristotle University Of Thessaloniki:
|
VILDAGLIPTIN blood pressure hypertension in type II diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Hypertension Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vascular Diseases Cardiovascular Diseases Vildagliptin |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013