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

NCT00530946 | Completed Phase 3 Results

• 1 other identifier: A3841058
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Hypertension; Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• Change in Systolic Blood Pressure

  Value at Week 8 minus value at baseline

  8 weeks

• Percent Change in Low Density Lipoprotein-Cholesterol

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

  8 weeks

Secondary Outcomes (9)

• Change in Systolic Blood Pressure From Baseline to Each Observation Point

  2 weeks, 4 weeks, and 8 weeks

• Change in Diastolic Blood Pressure From Baseline to Each Observation Point

  2 weeks, 4 weeks , and 8 weeks

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

  2 weeks, 4 weeks , and 8 weeks

• Percent Change in Total Cholesterol From Baseline to Each Observation Point

  2 weeks, 4 weeks , and 8 weeks

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

  2 weeks, 4 weeks , and 8 weeks

Study Arms (4)

CI-1038 2.5mg/5mg

ACTIVE COMPARATOR

Drug: Amlodipine 2.5mg/Atorvastatin 5mg

CI-1038 2.5mg/10mg

ACTIVE COMPARATOR

Drug: Amlodipine 2.5mg/Atorvastatin 10mg

CI-1038 5mg/5mg

ACTIVE COMPARATOR

Drug: Amlodipine 5mg/Atorvastatin 5mg

CI-1038 5mg/10mg

ACTIVE COMPARATOR

Drug: Amlodipine 5mg/Atorvastatin 10mg

Interventions

Amlodipine 2.5mg/Atorvastatin 5mg DRUG

Single pill combination, dosed once daily for 8 weeks

CI-1038 2.5mg/5mg

Amlodipine 2.5mg/Atorvastatin 10mg DRUG

Single pill combination, dosed once daily for 8 weeks

CI-1038 2.5mg/10mg

Amlodipine 5mg/Atorvastatin 5mg DRUG

Single pill combination, dosed once daily for 8 weeks

CI-1038 5mg/5mg

Amlodipine 5mg/Atorvastatin 10mg DRUG

Single pill combination, dosed once daily for 8 weeks

CI-1038 5mg/10mg

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (17)

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Location

Pfizer Investigational Site

Kitakyushu-shi, Fukuoka, Japan

Location

Pfizer Investigational Site

Kurume-shi, Fukuoka, Japan

Location

Pfizer Investigational Site

Maebaru-shi, Fukuoka, Japan

Location

Pfizer Investigational Site

Annaka, Gunma, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Location

Pfizer Investigational Site

Teine, Hokkaido, Japan

Location

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Location

Pfizer Investigational Site

Yamashitachō, Naka-ku, Kanagawa-ken, Japan

Location

Pfizer Investigational Site

Kita-ku, Osaka, Japan

Location

Pfizer Investigational Site

Koshigaya-shi, Saitama, Japan

Location

Pfizer Investigational Site

Chōfu, Tokyo, Japan

Location

Pfizer Investigational Site

Kiyose, Tokyo, Japan

Location

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shinagawa-Ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shinagawa, Tokyo, Japan

Location

Pfizer Investigational Site

Osaka, Japan

Location

Related Links

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

MeSH Terms

Conditions

Hypertension; Hypercholesterolemia

Interventions

Amlodipine; Atorvastatin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

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

ClinicalTrials.govCallCenter@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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 18, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: January 28, 2021
• Results First Posted: April 13, 2009

Record last verified: 2021-01

Locations

JP (17)