Clinical trial NCT00143234: Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels
Official title: Clinical Utility of Amlodipine/Atorvastatin to Improve Concomitant Cardiovascular Risk Factors of Hypertension and Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 1825
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to measure the effect of the amlodipine/atorvastatin combination pill in reducing both elevated blood pressure and cholesterol levels to levels suggested by guidelines


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of both elevated blood pressure and low density lipoprotein cholesterol levels, requiring medication

Exclusion Criteria:

* Patients with blood pressure adequately maintained at goal with or without medication
* Patients currently treated with both amlodipine and atorvastatin or not at blood pressure or lipid level while taking the highest dose of amlodipine or atorvastatin, respectively

Primary outcomes:
measure: To evaluate the efficacy of amlodipine/atorvastatin therapy by assessing the percentage of intent-to-treat subjects achieving both BP and lipid treatment goals (JNC VII and NCEP ATP III)
Secondary outcomes:
measure: To assess changes from baseline in lipid profile and systolic and diastolic BP after 14 weeks treatment; and in this secondary and the primary objectives stratified by prior BP and lipid therapy, and in diabetic subjects; safety
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: St. Leonards
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Southport
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Woolloongabba
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Heidelberg
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Prahran
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Fremantle
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: MG
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: MG
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: MG
city: Recife
country: Brazil
facility: Pfizer Investigational Site
state: PE
city: Botucatu
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Campinas
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Ribeirao Preto
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: SÃ£o Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RegiÃ³n Metropolitana
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Guatemala
country: Guatemala
facility: Pfizer Investigational Site
city: Pokfulam Road
country: Hong Kong
facility: Pfizer Investigational Site
city: Sai ying Pun
country: Hong Kong
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Nagpada Junction
city: New Delhi
country: India
facility: Pfizer Investigational Site
city: New Delhi
country: India
facility: Pfizer Investigational Site
city: New Delhi
country: India
facility: Pfizer Investigational Site
city: Jakarta
country: Indonesia
facility: Pfizer Investigational Site
city: Jakarta
country: Indonesia
facility: Pfizer Investigational Site
city: Surabaya
country: Indonesia
facility: Pfizer Investigational Site
city: Jerusalem
country: Israel
facility: Pfizer Investigational Site
city: Jerusalem
country: Israel
facility: Pfizer Investigational Site
city: Rehovot
country: Israel
facility: Pfizer Investigational Site
city: Tel Aviv
country: Israel
facility: Pfizer Investigational Site
city: Tel Hashomer
country: Israel
facility: Pfizer Investigational Site
city: Amman
country: Jordan
facility: Pfizer Investigational Site
city: Amman
country: Jordan
facility: Pfizer Investigational Site
city: Seo-gu
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Busan
city: Jung-gu
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Daegu
city: Dong-gu
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Kwangji
city: Anyang-city
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Kyungki-do
city: Guri-City
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Kyungki-do
city: Gangnam-gu
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Seoul
city: Yongdeungpo-gu
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Sasat
country: Kuwait
facility: Pfizer Investigational Site
city: Beirut
country: Lebanon
facility: Pfizer Investigational Site
city: Kubang Kerian
country: Malaysia
facility: Pfizer Investigational Site
state: Kelantan
city: Seremban
country: Malaysia
facility: Pfizer Investigational Site
state: Negeri Sembilan
city: Kuching
country: Malaysia
facility: Pfizer Investigational Site
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: D.F
city: Aguascalientes
country: Mexico
facility: Pfizer Investigational Site
city: Metepec
country: Mexico
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
city: Puebla
country: Mexico
facility: Pfizer Investigational Site
city: San Luis Potosi
country: Mexico
facility: Pfizer Investigational Site
city: Casablanca
country: Morocco
facility: Pfizer Investigational Site
city: Peshawar
country: Pakistan
facility: Pfizer Investigational Site
state: N.w.f.p.
city: Faisalabad
country: Pakistan
facility: Pfizer Investigational Site
state: Punjab
city: Islamabad
country: Pakistan
facility: Pfizer Investigational Site
state: Punjab
city: Lahore
country: Pakistan
facility: Pfizer Investigational Site
state: Punjab
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: San Juan
country: Philippines
facility: Pfizer Investigational Site
state: Metro Manila
city: Phippine General Hospital
country: Philippines
facility: Pfizer Investigational Site
state: Taft Avenue, Manila City
city: Filinvest, Alabang
country: Philippines
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Al-Khobar
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Worcester
country: South Africa
facility: Pfizer Investigational Site
state: Cape Province
city: Arcadia, Pretoria
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Midrand, Johannesburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Sunnyside, Pretoria
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Chatsworth
country: South Africa
facility: Pfizer Investigational Site
state: Natal
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Gauteng
country: South Africa
facility: Pfizer Investigational Site
city: Kwa-Zulu Natal
country: South Africa
facility: Pfizer Investigational Site
city: Niao-Sung Hsiang
country: Taiwan
facility: Pfizer Investigational Site
state: Kaohsiung
city: Guei-Shan Shiang
country: Taiwan
facility: Pfizer Investigational Site
state: Tau-Yuan Shian
city: Changhua City
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: KHET Rajathevee
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
city: Chiang Mai
country: Thailand
facility: Pfizer Investigational Site
city: Tunis
country: Tunisia
facility: Pfizer Investigational Site
city: Cebeci
country: Turkey
facility: Pfizer Investigational Site
state: Ankara
city: Sihhiye
country: Turkey
facility: Pfizer Investigational Site
state: Ankara
city: Haydarpasa
country: Turkey
facility: Pfizer Investigational Site
state: Istanbul
city: Alsancak
country: Turkey
facility: Pfizer Investigational Site
state: Izmir
city: Talas
country: Turkey
facility: Pfizer Investigational Site
state: Kayseri
city: Adana
country: Turkey
facility: Pfizer Investigational Site
city: Antalya
country: Turkey
facility: Pfizer Investigational Site
city: Diyarbakir
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Abu Dhabi
country: United Arab Emirates
facility: Pfizer Investigational Site
city: Dubai
country: United Arab Emirates
facility: Pfizer Investigational Site
city: Sharjah
country: United Arab Emirates
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: