Skip to main content
OpenTrials
Completed

NCT Number: NCT00412113

A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk

The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyslipidemia Cardiovascular Diseases Dyslipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with diagnosed hypertension receiving treatment with Norvasc 5 or 10 mg and who also have 3 additional cardiovascular risk factors, including dyslipidemia.

Exclusion criteria

  • Subjects who are taking the following prohibited medications within 14 days of screening: lipid-lowering therapy, calcium channel blocker other then Norvasc, >3 antihypertensive agents (including Norvasc)
  • Subjects that have not been on a stable dose of Norvasc for at least 4 weeks
  • Subjects with a history of coronary heart disease, stroke, or Pulmonary Vascular Disease (PVD)

Treatment and study plan

Amlodipine Besylate

Drug

Amlodipine besylate 5 mg

Amlodipine besylate/atorvastatin calcium single pill combination

Drug

Amlodipine/atorvastatin single pill combination 10/20 mg

Primary outcomes

  1. Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6

    Time frame: Week 6

    Number of subjects reaching dual goal of systolic blood pressure <140 millimeters of mercury (mmHg) and diastolic blood pressue of <90 mmHg and low density lipoprotein-cholesterol(LDL-C) <100 milligrams per deciliter(mg/dL)

  2. Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk

    Time frame: Week 6, baseline

    Framingham prediction of absolute 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol, and systolic blood pressure calculated at Week 6. Mean at observation minus mean at baseline.

Secondary outcomes

  1. Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4

    Time frame: Week 4

    Subjects achieving both the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC)-7 blood pressure goal of <140/90 mmHg and the National Cholesterol Education Program Adult Treatment Panel (NCEP/ATP) III Update low density lipoprotein-cholesterol (LDL-C) goal <100 mg/dL at Week 4.

  2. Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.

    Time frame: Week 4

    Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 4.

  3. Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.

    Time frame: Week 6

    Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 6.

  4. Subjects With LDL-C < 100 mg/dL at Week 4

    Time frame: Week 4

    Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 4.

  5. Subjects With LDL-C < 100 mg/dL at Week 6

    Time frame: Week 6

    Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 6.

  6. Subjects With BP < 140/90 mmHg at Week 4

    Time frame: Week 4

    Subjects achieving BP goal of <140/90 mmHg at week 4

  7. Subjects With BP < 140/90 mmHg at Week 6

    Time frame: Week 6

    Subjects achieving BP goal of <140/90 mmHg at week 6

  8. Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).

    Time frame: Week 4, baseline

    Mean at observation minus mean at baseline

  9. Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)

    Time frame: Week 4, baseline

    Mean at observation minus mean at baseline

  10. Change From Baseline to Week 4 in Pulse Rate

    Time frame: Week 4, baseline

    Mean at observation minus mean at baseline measured in beats per minute (bpm).

  11. Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)

    Time frame: Week 6, baseline

    Mean change at observation minus mean baseline.

  12. Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)

    Time frame: Week 6, baseline

    Change from mean at observation minus mean at baseline

  13. Change From Baseline to Week 6 in Pulse Rate

    Time frame: Week 6, baseline

    Mean at observation minus mean at baseline

  14. Change From Baseline in LDL at Week 4.

    Time frame: Week 4, baseline

    Change: mean of observation minus mean at baseline.

  15. Change From Baseline in High Density Lipoprotein (HDL) at Week 4.

    Time frame: Week 4, baseline

    Mean change at observation minus baseline.

  16. Change in Total Cholesterol (TC) From Baseline to Week 4.

    Time frame: Week 4, baseline

    Mean change at observation minus baseline.

  17. Change From Baseline in Triglycerides (TG) to Week 4.

    Time frame: Week 4, baseline

    Mean change at observation minus baseline

  18. Change From Baseline in LDL at Week 6.

    Time frame: Week 6, baseline

    Mean change at observation minus baseline.

  19. Change From Baseline in HDL at Week 6.

    Time frame: Week 6, baseline

    Mean change at observation minus baseline.

  20. Change From Baseline in Total Cholesterol (TC) to Week 6.

    Time frame: Week 6, baseline

    Mean change at observation minus baseline.

  21. Change From Baseline in Triglycerides (TG) at Week 6.

    Time frame: Week 6 , baseline

    Mean change at observation minus mean baseline.

  22. Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.

    Time frame: Week 4, baseline

    Framingham prediction of absolute 10-year risk of CHD outcomes (MI or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol and systolic blood pressure calculated at Week 4. Mean at observation minus mean at baseline.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

A 6-Week, Prospective, Randomized, Double-Blind, Double-Dummy Phase IV Clinical Trial Designed to Evaluate the Efficacy of an Aggressive Multi-Risk Factor Management Strategy With Caduet (A3841045) Versus a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensive Subjects With Additional Risk Factors.

Acronym: TOGETHER

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 15, 2006
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.