--- a +++ b/matching/trials/NCT00143195.xml @@ -0,0 +1,231 @@ +<?xml version="1.0" encoding="UTF-8"?> +<clinical_study rank="189601"> + <!-- This xml conforms to an XML Schema at: + https://clinicaltrials.gov/ct2/html/images/info/public.xsd + and an XML DTD at: + https://clinicaltrials.gov/ct2/html/images/info/public.dtd --> + <required_header> + <download_date>ClinicalTrials.gov processed this data on December 16, 2015</download_date> + <link_text>Link to the current ClinicalTrials.gov record.</link_text> + <url>https://clinicaltrials.gov/show/NCT00143195</url> + </required_header> + <id_info> + <org_study_id>A0531076</org_study_id> + <nct_id>NCT00143195</nct_id> + </id_info> + <brief_title>Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina</brief_title> + <acronym>ANISSA</acronym> + <official_title>Open Label Study Comparing Amlodipine vs Long-Acting Nitrates in Patients With Chronic Stable Angina.</official_title> + <sponsors> + <lead_sponsor> + <agency>Pfizer</agency> + <agency_class>Industry</agency_class> + </lead_sponsor> + </sponsors> + <source>Pfizer</source> + <oversight_info> + <authority>Greece: National Organization of Medicines</authority> + </oversight_info> + <brief_summary> + <textblock> + The objective of study is to compare the anti-ischemic efficacy and safety profiles of once + daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and + symptomatic myocardial ischemia + </textblock> + </brief_summary> + <overall_status>Completed</overall_status> + <start_date>April 2001</start_date> + <completion_date>January 2005</completion_date> + <phase>Phase 4</phase> + <study_type>Interventional</study_type> + <study_design>Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment</study_design> + <primary_outcome> + <measure>Evaluate the time to 1mm ST depression</measure> + </primary_outcome> + <secondary_outcome> + <measure>The number of patients experiencing angina attacks The frequency of hospitalizations due to angina attacks Time to onset of 1mm ST segment depression Total external workload performed Safety</measure> + </secondary_outcome> + <enrollment>200</enrollment> + <condition>Myocardial Ischemia</condition> + <intervention> + <intervention_type>Drug</intervention_type> + <intervention_name>Amlodipine</intervention_name> + </intervention> + <intervention> + <intervention_type>Drug</intervention_type> + <intervention_name>iso- 5 - mononitrate</intervention_name> + </intervention> + <intervention> + <intervention_type>Procedure</intervention_type> + <intervention_name>Blood tests</intervention_name> + </intervention> + <intervention> + <intervention_type>Procedure</intervention_type> + <intervention_name>Exercise Stress Test</intervention_name> + </intervention> + <eligibility> + <criteria> + <textblock> + Inclusion Criteria: + + - Outpatients > =18 years of age with diagnosed clinically stable angina pectoris + + Exclusion Criteria: + + - Patients with congestive heart failure, clinically significant cardiovascular + disease, standing systolic blood pressure of less than 100mmHg, concomitant + anti-anginal therapies similar to sublingual NTG + </textblock> + </criteria> + <gender>Both</gender> + <minimum_age>18 Years</minimum_age> + <maximum_age>N/A</maximum_age> + <healthy_volunteers>No</healthy_volunteers> + </eligibility> + <overall_official> + <last_name>Pfizer CT.gov Call Center</last_name> + <role>Study Director</role> + <affiliation>Pfizer</affiliation> + </overall_official> + <location> + <facility> + <name>Pfizer Investigational Site</name> + <address> + <city>Athens</city> + <state>Attika</state> + <zip>11527</zip> + <country>Greece</country> + </address> + </facility> + </location> + <location> + <facility> + <name>Pfizer Investigational Site</name> + <address> + <city>Athens</city> + <country>Greece</country> + </address> + </facility> + </location> + <location> + <facility> + <name>Pfizer Investigational Site</name> + <address> + <city>Athens</city> + <zip>123 51</zip> + <country>Greece</country> + </address> + </facility> + </location> + <location> + <facility> + <name>Pfizer Investigational Site</name> + <address> + <city>Holargos/Athens</city> + <zip>11525</zip> + <country>Greece</country> + </address> + </facility> + </location> + <location> + <facility> + <name>Pfizer Investigational Site</name> + <address> + <city>Loannina</city> + <zip>45500</zip> + <country>Greece</country> + </address> + </facility> + </location> + <location> + <facility> + <name>Pfizer Investigational Site</name> + <address> + <city>N. Ionia</city> + <zip>143 88</zip> + <country>Greece</country> + </address> + </facility> + </location> + <location> + <facility> + <name>Pfizer Investigational Site</name> + <address> + <city>Patra</city> + <zip>26335</zip> + <country>Greece</country> + </address> + </facility> + </location> + <location> + <facility> + <name>Pfizer Investigational Site</name> + <address> + <city>Rio, Patra</city> + <zip>26499</zip> + <country>Greece</country> + </address> + </facility> + </location> + <location> + <facility> + <name>Pfizer Investigational Site</name> + <address> + <city>Thessaloniki</city> + <zip>546 36</zip> + <country>Greece</country> + </address> + </facility> + </location> + <location> + <facility> + <name>Pfizer Investigational Site</name> + <address> + <city>Thessaloniki</city> + <zip>54639</zip> + <country>Greece</country> + </address> + </facility> + </location> + <location> + <facility> + <name>Pfizer Investigational Site</name> + <address> + <city>Voula/Athens</city> + <country>Greece</country> + </address> + </facility> + </location> + <location> + <facility> + <name>Pfizer Investigational Site</name> + <address> + <city>Zakynthos</city> + <zip>29100</zip> + <country>Greece</country> + </address> + </facility> + </location> + <location_countries> + <country>Greece</country> + </location_countries> + <link> + <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0531076&StudyName=Amlodipine+vs+NItrates+Study+in+Patients+with+Chronic+Stable++Angina+%28ANISSA%29</url> + <description>To obtain contact information for a study center near you, click here.</description> + </link> + <verification_date>April 2007</verification_date> + <lastchanged_date>April 17, 2007</lastchanged_date> + <firstreceived_date>August 31, 2005</firstreceived_date> + <has_expanded_access>No</has_expanded_access> + <condition_browse> + <!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm --> + <mesh_term>Angina, Stable</mesh_term> + <mesh_term>Coronary Artery Disease</mesh_term> + <mesh_term>Myocardial Ischemia</mesh_term> + </condition_browse> + <intervention_browse> + <!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm --> + <mesh_term>Amlodipine</mesh_term> + </intervention_browse> + <!-- Results have not yet been posted for this study --> +</clinical_study>