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

NCT01190007 | Completed Phase 4 Results

• 1 other identifier: A3841064
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 20

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.

Conditions

Hypertension; Hypercholesterolemia; Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• 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.

  52 weeks

Secondary Outcomes (11)

• Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia

  Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

• Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia

  Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

• Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia

  Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

• Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia

  Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

• Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit

  Weeks 4, 12, 24, and 52

Study Arms (1)

Caduet

EXPERIMENTAL

Drug: Caduet

Interventions

Caduet DRUG

One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks

Caduet

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (20)

Healthcare Corporation MEDOC Medical Dock&Clinic

Nagoya, Aichi-ken, Japan

Location

Beppu Medical Clinic

Dazaifu, Fukuoka, Japan

Location

Morizono medical clinic

Kitakyushu, Fukuoka, Japan

Location

Gakkentoshi Clinic

Nishiku, Fukuoka, Japan

Location

Department of internal gastro-intestinal medicine Ohshima clinic

Sapporo, Hokkaido, Japan

Location

Oofuji Clinic

Amagasaki, Hyōgo, Japan

Location

Mizutani Clinic

Kobe, Hyōgo, Japan

Location

Nada Clinic

Kobe, Hyōgo, Japan

Location

Idaimae-naika Clinic

Kawasaki, Kanagawa, Japan

Location

Sakakibara Clinic, Wakaumekai Medical Corporation

Yokohama, Kanagawa, Japan

Location

Masunaga Clinic

Fujimi, Saitama, Japan

Location

Sugiura Clinic

Kawaguchi, Saitama, Japan

Location

Masuda Clinic

Adachi-ku, Tokyo, Japan

Location

Wakasugi Family Clinic

Arakawa-ku, Tokyo, Japan

Location

Medical Care Law Person Corporation Kenseikai, Kobayashi Internal Medicine Clinic

Koto-ku, Tokyo, Japan

Location

Banno Clinic

Ohta-ku, Tokyo, Japan

Location

Hatano Medical Clinic

Setagaya-ku, Tokyo, Japan

Location

Suzuki Circulatory Medical Clinic

Setagaya-ku, Tokyo, Japan

Location

Yano Cardiovascular Clinic

Fukuoka, Japan

Location

Nakaoka Clinic

Osaka, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypertension; Hypercholesterolemia; Angina Pectoris

Interventions

amlodipine, atorvastatin drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 27, 2010
• Study Start: August 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: January 28, 2021
• Results First Posted: December 3, 2012

Record last verified: 2021-01

Locations

JP (20)