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Completed

NCT Number: NCT00530946

A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin

To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female >=20 to <80 years of age at Visit 1.
  • The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and <180 mmHg,
  • LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).

Exclusion criteria

  • Subjects who had experienced the following coronary artery disease within the past 3 months.
  • Myocardial infarction
  • Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass grafting)
  • Any clinically meaningful valvular disease
  • Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.

Treatment and study plan

Amlodipine 2.5mg/Atorvastatin 5mg

Drug

Single pill combination, dosed once daily for 8 weeks

Amlodipine 2.5mg/Atorvastatin 10mg

Drug

Single pill combination, dosed once daily for 8 weeks

Amlodipine 5mg/Atorvastatin 5mg

Drug

Single pill combination, dosed once daily for 8 weeks

Amlodipine 5mg/Atorvastatin 10mg

Drug

Single pill combination, dosed once daily for 8 weeks

Primary outcomes

  1. Change in Systolic Blood Pressure

    Time frame: 8 weeks

    Value at Week 8 minus value at baseline

  2. Percent Change in Low Density Lipoprotein-Cholesterol

    Time frame: 8 weeks

    Percent of "value at Week 8 minus value at baseline" over value at baseline

Secondary outcomes

  1. Change in Systolic Blood Pressure From Baseline to Each Observation Point

    Time frame: 2 weeks, 4 weeks, and 8 weeks

    Value at Week 2, Week 4, or Week 8 minus value at baseline

  2. Change in Diastolic Blood Pressure From Baseline to Each Observation Point

    Time frame: 2 weeks, 4 weeks , and 8 weeks

    Value at Week 2, Week 4, or Week 8 minus value at baseline

  3. Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point

    Time frame: 2 weeks, 4 weeks , and 8 weeks

    Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

  4. Percent Change in Total Cholesterol From Baseline to Each Observation Point

    Time frame: 2 weeks, 4 weeks , and 8 weeks

    Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

  5. Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point

    Time frame: 2 weeks, 4 weeks , and 8 weeks

    Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

  6. Percent Change in Triglycerides From Baseline to Each Observation Point

    Time frame: 2 weeks, 4 weeks , and 8 weeks

    Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

  7. Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point

    Time frame: 2 weeks, 4 weeks, and 8 weeks

    Value at Week 2, Week 4, or Week 8 minus value at baseline

  8. Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point

    Time frame: 2 weeks, 4 weeks , and 8 weeks

    Value at Week 2, Week 4, or Week 8 minus value at baseline

  9. Change in Apolipoprotein B From Baseline to Each Observation Point

    Time frame: 2 weeks, 4 weeks, and 8 weeks

    Value at Week 2, Week 4, or Week 8 minus value 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 Multi-Center, Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin In The Treatment Of Concurrent Hypertension And Hyper-LDL-Cholesterolemia

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 18, 2007
Registry last updated
Jan 28, 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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