<?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>
