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Trial record 54 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

The SCCS Polypill Pilot Trial

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ClinicalTrials.gov Identifier: NCT02278471
Recruitment Status : Completed
First Posted : October 30, 2014
Results First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Wang, Vanderbilt University

Brief Summary:
In this study the investigators will examine the effect of the polypill on medication adherence, systolic blood pressure, and LDL cholesterol over a 12 month span.

Condition or disease Intervention/treatment Phase
Hypertension Hyperlipidemia Drug: Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide) Phase 2

Detailed Description:

The purpose of this study is to assess if a polypill-based approach to primary CVD prevention is feasible in a low socioeconomic status population. The study will assess whether a polypill approach is associated with better cardiovascular risk factor control compared with usual care.

The polypill will be supplied as a compounded pill containing atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg, and hydrochlorothiazide 12.5 mg. The medications in the polypill have been extensively evaluated individually and in combination. Each of the medications in the polypill is approved by the United States Food and Drug Administration (FDA) and widely administered in the US for the treatment of and prevention of cardiovascular disease. The doses of each component medication included in the polypill are low, which should minimize the chance of any potential side-effects.

In this study we assess medication adherence, systolic blood pressure, and LDL cholesterol over a 12 month span, in subjects taking the polypill versus subjects under usual care.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The SCCS Polypill Pilot Trial
Actual Study Start Date : December 2015
Actual Primary Completion Date : June 27, 2018
Actual Study Completion Date : June 27, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
Subjects in this arm will not receive any investigational medications. They will remain on the same care that they are use to receiving.
Experimental: Polypill

The study medication will be a fixed-dose combination pill (polypill) containing: Atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg, and hydrochlorothiazide 12.5 mg.

Polypill will be taken once daily.

Drug: Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)



Primary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: 12 months ]
    polypill versus usual care

  2. Medication Adherence-Percentage of Pills Taken [ Time Frame: 12 months ]
    polypill arm-evaluation via pill counts.

  3. LDL Cholesterol [ Time Frame: 12 months ]
    Polypill versus usual care


Secondary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: 2 months ]
    polypill versus usual care

  2. Medication Adherence [ Time Frame: 2 months ]
    polypill-percentage of pills taken, evaluated via pill counts

  3. Drug Metabolite Profile [ Time Frame: 12 months ]

    LC/MS/MS-based drug metabolite profile assay screen in the polypill arm.

    Note: Due to budgetary constraints, we did not immediately perform measurement of the secondary biomarker endpoints at the conclusion of the trial. We have secured alternate funding to perform biomarker measurements (glycemic markers, inflammatory profiles, and drug metabolites), which will be conducted in the next year.


  4. LDL Cholesterol [ Time Frame: 2 months ]
    polypill versus usual care

  5. Insulin Resistance [ Time Frame: Baseline and 12 months ]

    Measurement of HOMA-IR using fasting glucose and insulin.

    Note: Due to budgetary constraints, we did not immediately perform measurement of the secondary biomarker endpoints at the conclusion of the trial. We have secured alternate funding to perform biomarker measurements (glycemic markers, inflammatory profiles, and drug metabolites), which will be conducted in the next year.


  6. Inflammatory Profile [ Time Frame: Baseline and 12 months ]

    Plasma levels of IL-17, IFN-g, IL-6, IL-10, high sensitivity C-reactive protein, TNFa, IL-4.

    Note: Due to budgetary constraints, we did not immediately perform measurement of the secondary biomarker endpoints at the conclusion of the trial. We have secured alternate funding to perform biomarker measurements (glycemic markers, inflammatory profiles, and drug metabolites), which will be conducted in the next year.




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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled at the SCCS site in Mobile, Alabama, obtain care at Franklin Primary Health Center, or live in the surrounding area.
  • Aged 45-75 years
  • Baseline systolic blood pressure ≥120 mm Hg. In this open-label trial, the study physicians are permitted to prescribe any additional medication deemed appropriate to achieve blood pressure control.

Exclusion Criteria:

  • History of coronary heart disease or stroke
  • History of cancer, except for basal cell skin cancer
  • History of liver disease, not including chronic, clinically-stable hepatitis
  • Laboratory evidence of hepatic dysfunction (an alanine aminotransferase level more than two times the upper limit of the normal range)
  • Known renal disease, estimated creatinine clearance < 60
  • Current use of more than 2 anti-hypertensive medications
  • LDL cholesterol ≥190 mg/dl
  • Insulin-dependent diabetes
  • Known intolerance to any of the components of the polypill
  • Potassium <3.4 or >5.5 mEq/L
  • Use of medications that interact with statins, including those affecting the cytochrome P450 system
  • Current use of diuretics for indications other than hypertension
  • Comorbidities that might be expected to limit lifespan during the 12-month follow-up period
  • Inability to provide consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278471


Locations
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United States, Alabama
Franklin Primary Health Center
Mobile, Alabama, United States, 36603
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Thomas J Wang, MD Vanderbilt Univeristy
  Study Documents (Full-Text)

Documents provided by Thomas Wang, Vanderbilt University:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Wang, Director of the Division of Cardiovascular Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02278471     History of Changes
Other Study ID Numbers: 141583
First Posted: October 30, 2014    Key Record Dates
Results First Posted: October 1, 2019
Last Update Posted: October 1, 2019
Last Verified: September 2019
Keywords provided by Thomas Wang, Vanderbilt University:
combination pill
polypill
primary prevention
Additional relevant MeSH terms:
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Losartan
Hydrochlorothiazide
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors