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Caduet in an Untreated Subject Population (CUSP)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00332761
First received: June 1, 2006
Last updated: August 19, 2008
Last verified: August 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
Dyslipidemia
 Drug: Caduet
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:

Drug Information available for: Caduet
U.S. FDA Resources

Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 8.
  • Change from Baseline to Week 4 in SBP, DBP, and Framingham 10-year CHD risk score.
  • Percent change from Baseline to Week 4 in LDL-C, HDL, TC, and TG.
  • The percentage of study subjects achieving each of the following goals at Week 4: SBP, DBP, and LDL-C.
  • Change from Baseline to Week 8 in SBP, DBP, and Framingham 10-year CHD risk score.
  • Percent change from Baseline to Week 8 in LDL-C, HDL, TC, and TG.
  • The percentage of study subjects achieving each of SBP, DBP, and LDL-C goals at Week 8.

Estimated Enrollment: 220
Study Start Date: June 2006
Study Completion Date: September 2007
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332761

  Show 34 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00332761     History of Changes
Other Study ID Numbers: A3841046
Study First Received: June 1, 2006
Last Updated: August 19, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine, atorvastatin drug combination
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Calcium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on May 22, 2013