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Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients

Primary Purpose

Hypertension, Hypercholesterolemia, Angina Pectoris

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Caduet
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject with both hypertension and hypercholesterolemia must meet the following (1), and the following (2) or (3):
  • (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0)
  • (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2
  • (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and TG < 400 mg/dL at Week -2
  • Subject with both angina pectoris and hypercholesterolemia must meet the following (1), and the following (2) or (3):
  • (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and who meet the following criteria; Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0), and subjects with clinically stable of angina pectoris
  • (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2
  • (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and TG < 400 mg/dL at Week -2

Exclusion Criteria:

  • Subjects who need three or more multi-antihypertensive therapies to achieve the target BP level or uncontrolled status of hypertension at Week 0 (V1); the target BP level is defined as systolic blood pressure < 140mmHg and diastolic blood pressure < 90 mmHg.
  • Uncontrolled or uncontrollable status of hypercholesterolemia at Week -2; A LDL-C ≥ 160 mg/dL even though Atorvastatine 10 mg has administrated

Sites / Locations

  • Healthcare Corporation MEDOC Medical Dock&Clinic
  • Beppu Medical Clinic
  • Morizono medical clinic
  • Gakkentoshi Clinic
  • Department of internal gastro-intestinal medicine Ohshima clinic
  • Oofuji Clinic
  • Mizutani Clinic
  • Nada Clinic
  • Idaimae-naika Clinic
  • Sakakibara Clinic, Wakaumekai Medical Corporation
  • Masunaga Clinic
  • Sugiura Clinic
  • Masuda Clinic
  • Wakasugi Family Clinic
  • Medical Care Law Person Corporation Kenseikai, Kobayashi Internal Medicine Clinic
  • Banno Clinic
  • Hatano Medical Clinic
  • Suzuki Circulatory Medical Clinic
  • Yano Cardiovascular Clinic
  • Nakaoka Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Caduet

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

Secondary Outcome Measures

Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Value at each visits minus value at baseline
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Value at each visits minus value at baseline
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Value at each visits minus value at baseline
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Value at each visits minus value at baseline
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Percent Change From Baseline in Total Cholesterol (TC) at Each Visit
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Percent Change From Baseline in Triglyceride (TG) at Each Visit
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Value at each visits minus value at baseline
Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Value at each visits minus value at baseline
Percent Change From Baseline in Apolipoprotein B at Each Visit
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100

Full Information

First Posted
August 5, 2010
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01190007
Brief Title
Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
Official Title
A Multi-Center, Open Label Study To Evaluate Long Term Safety Of Caduet In Patient With Both Of Hypertension And Hypercholesterolemia, Or With Both Of Angina Pectoris And Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period in Japanese patients with both of hypertension and hypercholesterolemia, or with both angina pectoris and hypercholesterolemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hypercholesterolemia, Angina Pectoris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caduet
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Caduet
Intervention Description
One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Description
Value at each visits minus value at baseline
Time Frame
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Title
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Description
Value at each visits minus value at baseline
Time Frame
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Title
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Description
Value at each visits minus value at baseline
Time Frame
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Title
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Description
Value at each visits minus value at baseline
Time Frame
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Title
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit
Description
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Time Frame
Weeks 4, 12, 24, and 52
Title
Percent Change From Baseline in Total Cholesterol (TC) at Each Visit
Description
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Time Frame
Weeks 4, 12, 24, and 52
Title
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Description
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Time Frame
Weeks 4, 12, 24, and 52
Title
Percent Change From Baseline in Triglyceride (TG) at Each Visit
Description
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Time Frame
Week 4, 12, 24, and 52
Title
Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Description
Value at each visits minus value at baseline
Time Frame
Weeks 4, 12, 24, and 52
Title
Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Description
Value at each visits minus value at baseline
Time Frame
Weeks 4, 12, 24, and 52
Title
Percent Change From Baseline in Apolipoprotein B at Each Visit
Description
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Time Frame
Week 4, 12, 24, and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject with both hypertension and hypercholesterolemia must meet the following (1), and the following (2) or (3): (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0) (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2 (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and TG < 400 mg/dL at Week -2 Subject with both angina pectoris and hypercholesterolemia must meet the following (1), and the following (2) or (3): (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and who meet the following criteria; Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0), and subjects with clinically stable of angina pectoris (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2 (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and TG < 400 mg/dL at Week -2 Exclusion Criteria: Subjects who need three or more multi-antihypertensive therapies to achieve the target BP level or uncontrolled status of hypertension at Week 0 (V1); the target BP level is defined as systolic blood pressure < 140mmHg and diastolic blood pressure < 90 mmHg. Uncontrolled or uncontrollable status of hypercholesterolemia at Week -2; A LDL-C ≥ 160 mg/dL even though Atorvastatine 10 mg has administrated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Healthcare Corporation MEDOC Medical Dock&Clinic
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Beppu Medical Clinic
City
Dazaifu
State/Province
Fukuoka
Country
Japan
Facility Name
Morizono medical clinic
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
Gakkentoshi Clinic
City
Nishi-ku
State/Province
Fukuoka
Country
Japan
Facility Name
Department of internal gastro-intestinal medicine Ohshima clinic
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Oofuji Clinic
City
Amagasaki
State/Province
Hyogo
Country
Japan
Facility Name
Mizutani Clinic
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Nada Clinic
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Idaimae-naika Clinic
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Sakakibara Clinic, Wakaumekai Medical Corporation
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Masunaga Clinic
City
Fujimi
State/Province
Saitama
Country
Japan
Facility Name
Sugiura Clinic
City
Kawaguchi
State/Province
Saitama
Country
Japan
Facility Name
Masuda Clinic
City
Adachi-ku
State/Province
Tokyo
Country
Japan
Facility Name
Wakasugi Family Clinic
City
Arakawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Medical Care Law Person Corporation Kenseikai, Kobayashi Internal Medicine Clinic
City
Koto-ku
State/Province
Tokyo
Country
Japan
Facility Name
Banno Clinic
City
Ohta-ku
State/Province
Tokyo
Country
Japan
Facility Name
Hatano Medical Clinic
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Suzuki Circulatory Medical Clinic
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Yano Cardiovascular Clinic
City
Fukuoka
Country
Japan
Facility Name
Nakaoka Clinic
City
Osaka
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3841064&StudyName=Open%20Label%20Study%20To%20Evaluate%20The%20Long-Term%20Safety%20Profiles%20Of%20Caduet%20In%20Japanese%20Patients
Description
To obtain contact information for a study center near you, click here.

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Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients

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