NCT01364675

Brief Summary

The purpose of this study is to determine whether treating pre-diabetic \& pre-hypertensive individuals using multiple drugs intervention (anti-hypertensive drugs (i.e., ACEI) plus anti-glycemic drug (i.e., metformin) plus anti-hyperlipidemic drug (statin)) would lower Cardiovascular Disease (CVD) events.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 2, 2011

Status Verified

May 1, 2011

Enrollment Period

4.5 years

First QC Date

May 31, 2011

Last Update Submit

June 1, 2011

Conditions

Pre-diabetesPre-hypertension

Keywords

Impaired fasting glucoseImpaired glucose tolerancePre-diabetesPre-hypertensivesCardiovascular events

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular Events

    Fatal or Non-fatal Myocardial Infarction, Angina Pectoris, Congestive Heart Failure, Coronary Revascularization, Fatal or Non-fatal Stroke, Amputation of Lower Extremities (non-traumatic cause)

    4-year

Secondary Outcomes (4)

  • Micro-vascular Complications

    4-year

  • Cumulative Incidence of Diabetes

    4-year

  • Cumulative Incidence of Hypertension

    4-year

  • Incidence of Individual Cardiovascular Disease

    4-year

Study Arms (2)

Metformin+Enalapril+Simvastatin

EXPERIMENTAL
Drug: Metformin+Enalapril+Simvastatin

Placebo tablet

PLACEBO COMPARATOR
Drug: Placebo tablet

Interventions

Metformin+Enalapril+SimvastatinDRUG

Poly-pill - composed of Metformin (500 mg), Enalapril (10 mg) and Simvastatin (10 mg) in single tablet given once daily after dinner for 4 years

Also known as: Poly-pill
Metformin+Enalapril+Simvastatin
Placebo tabletDRUG

Identical Placebo Tablet

Also known as: Placebo
Placebo tablet

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pre-diabetes
  • Pre-hypertensives
  • LDL-Cholesterol \>= 100 \< 190 mg/dl
  • BMI \>= 23
  • Estimated GFR \>= 60 ml/min/1.73 m2 (MDRD equation)
  • Willing to participate and provide written inform consent

You may not qualify if:

  • Current involved in other studied medications
  • Regular use of corticosteroids
  • Current use of weight loss medication
  • History of renal disease
  • Active liver disease including jaundice, chronic hepatitis with ALT \>= 2.5 the upper normal limit
  • Active malignancy
  • Major psychiatric disorder
  • Diseases and medications that affect glucose tolerance (e.g. pheochromocytoma, Cushing's syndrome, acromegaly, steroid-dependent asthma, protease inhibitors, antipsychotics)
  • Nursing women, pregnant women, or those that plan to become pregnant in the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ubon ratchathani Public Health Office

Muang District, Changwat Ubon Ratchathani, 34000, Thailand

Location

MeSH Terms

Conditions

Glucose IntolerancePrehypertension

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Phisitt Vejakama, M.D.

    Section for clinical epidemiology and bioststistics, Faculty of medicine, Ramathibodi hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Phisitt Vejakama, M.D.

CONTACT

66849562882toughcountrydoc@gmail.com

Ammarin Thakkinstian, Ph.D.

CONTACT

66818436266raatk@mahidol.ac.th

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 2, 2011

Study Start

January 1, 2012

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

June 2, 2011

Record last verified: 2011-05

Locations

TH(1)