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Completed

NCT Number: NCT00332761

Caduet in an Untreated Subject Population

The purpose of this study is to determine if Caduet will lower blood pressure to <140/90 mmHg and lower LDL Cholesterol to <100 mg/dL in subjects with hypertension and dyslipidemia who are not currently being treated for these medical conditions.

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemia Dyslipidemias 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, Jonesboro, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects who were recently diagnosed with both hypertension and dyslipidemia and who are not yet taking any medications for these conditions OR subjects with both hypertension and dyslipidemia who were previously treated with antihypertensive and/or lipid lowering medications but discontinued these medications for at least 3 months prior to the Screening visit.
  • SBP 140-169 mmHg and/or DBP 90-105 mmHg, LDL-C 110-160 mg/dL

Exclusion criteria

  • Subjects with a history of MI, angina, coronary artery bypass or intra-coronary interventions, stroke, TIA, CHF or cardiomyopathy requiring treatment.
  • Subjects with a known history of Type I or Type 2 Diabetes Mellitus or a fasting blood glucose > 126 mg/dL at the Screening visit.

Treatment and study plan

Caduet

Drug

Primary outcomes

  1. The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4.

Secondary outcomes

  1. The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 8.

  2. Change from Baseline to Week 4 in SBP, DBP, and Framingham 10-year CHD risk score.

  3. Percent change from Baseline to Week 4 in LDL-C, HDL, TC, and TG.

  4. The percentage of study subjects achieving each of the following goals at Week 4: SBP, DBP, and LDL-C.

  5. Change from Baseline to Week 8 in SBP, DBP, and Framingham 10-year CHD risk score.

  6. Percent change from Baseline to Week 8 in LDL-C, HDL, TC, and TG.

  7. The percentage of study subjects achieving each of SBP, DBP, and LDL-C goals at Week 8.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

An 8-Week Randomized, Double-Blind, Placebo-Controlled Trial Examining The Efficacy And Safety Of Caduet® In Simultaneously Achieving Blood Pressure And Lipid Goals In An Untreated Hypertensive And Dyslipidemic Subject Population. (CUSP - Caduet in Untreated Subject Population)

Acronym: CUSP

Important dates

Study start
2006
Study completion
2007
First posted
Jun 2, 2006
Registry last updated
Jan 27, 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.

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