Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension - Tabular View

Tracking Information

First Received Date ^ICMJE

January 24, 2006

Last Updated Date

May 12, 2009

Start Date ^ICMJE

April 2006

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy: Change from baseline in seated trough cuff diastolic blood pressure after eight weeks of treatment

Original Primary Outcome Measures ^ICMJE

Change from baseline in the mean in-clinic seated trough cuff diastolic blood pressure after 8 weeks of treatment

Change History

Complete list of historical versions of study NCT00281580 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy: change after 8 wks in: seated cuff SBP; % pts with BP response to treatment; standing DBP and SBP; ABPM overall and hourly BP changes. Safety:AEs, Labs, ECG, Orthostatic BP changes, PR

Original Secondary Outcome Measures ^ICMJE

Change from baseline in the mean in-clinic seated trough cuff systolic blood pressure, percentage of patients responding to treatment and 24h blood pressure control as assessed by Ambulatory Blood Pressure Monitoring.

Descriptive Information

Brief Title ^ICMJE

Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension

Official Title ^ICMJE

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 4x4 Factorial Design Trial to Evaluate Telmisartan 20, 40 and 80 mg Tablets in Combination With Amlodipine 2.5, 5 and 10 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-Study

Brief Summary

To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pressure.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Telmisartan
Drug: Amlodipine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1461

Completion Date

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male and female patients >=18 years of age with Stage I or II hypertension defined as:
a mean seated cuff diastolic blood pressure >=95 and <=119 mmHg Main

Exclusion Criteria:

Pregnant
breast-feeding
unwilling to use birth control during the study
secondary hypertension, SBP>=180 mmHg
DBP>=120 mmHg
severe renal dysfunction
hepatic insufficiency
stroke within the last 6 months
myocardial infarction, cardiac surgery, per cutaneous transluminal coronary angioplasty
unstable angina or coronary artery bypass graft within the past three months
unstable or uncontrolled diabetes
history of angioedema of either of the study drugs and hypersensitivity to the study drugs

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Brazil, Mexico, South Africa

Administrative Information

NCT ID ^ICMJE

NCT00281580

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study ID Numbers ^ICMJE

1235.1

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP