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Research Study To Test Carvedilol CR + Lisinopril Versus Lisinopril + Placebo In Patients With High Blood Pressure

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: carvedilol controlled release/lisinopril (Drug); lisinopril + placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2 essential hypertension who are not at target blood pressure (<140/90mmHg) at Baseline. Subjects will be randomized to receive either carvedilol CR + lisinopril or lisinopril + placebo. Subjects will be uptitrated over a 6 week period until target blood pressure (<140/90mmHg) is met. The primary objective of the study is to compare the proportion of subjects who achieve target blood pressure after 6 weeks of treatment.

Clinical Details

Official title: COR111096, A Randomized, Double-Blind, Active-Controlled, Parallel Group, Multicenter Study Comparing the Proportion of Subjects With Stage 1 or 2 Essential Hypertension Who Achieve Target Blood Pressure While Receiving Either Carvedilol CR + Lisinopril or Lisinopril Monotherapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment

Secondary outcome: Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) and Sitting Diastolic Blood Pressure (sDBP) at Week 6

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female age 18-80 years; stage 1 or 2 hypertension currently receiving 0 or 1

antihypertensive medication; mean sitting systolic blood pressure >/=140mmHg to /=90 to - Subject taking two or more antihypertensive medications, known contraindication to

angiotensin-converting enzyme (ACE) inhibitors or alpha- or beta-blocker therapy, subject has Type 1 or Type 2 diabetes

Locations and Contacts

GSK Investigational Site, Mobile, Alabama 36617, United States

GSK Investigational Site, Chandler, Arizona 77030, United States

GSK Investigational Site, Glendale, Arizona 85308, United States

GSK Investigational Site, Goodyear, Arizona 85395, United States

GSK Investigational Site, Litchifield Park/Arizona, Arizona 85340, United States

GSK Investigational Site, Phoenix, Arizona 85032, United States

GSK Investigational Site, Tucson, Arizona 85745, United States

GSK Investigational Site, Anaheim, California 92801, United States

GSK Investigational Site, Beuna Park, California 90620, United States

GSK Investigational Site, Fountain Valley, California 92708, United States

GSK Investigational Site, Poway, California 92064, United States

GSK Investigational Site, San Ramon, California 94583, United States

GSK Investigational Site, Tustin, California 92780, United States

GSK Investigational Site, Vista, California 92081, United States

GSK Investigational Site, Coral Gables, Florida 33134, United States

GSK Investigational Site, Deland, Florida 32720, United States

GSK Investigational Site, Fort Lauderdale, Florida 33308, United States

GSK Investigational Site, Hollywood, Florida 33023, United States

GSK Investigational Site, Miami, Florida 33156, United States

GSK Investigational Site, Pembroke Pines, Florida 33024, United States

GSK Investigational Site, Tamarac, Florida 33321, United States

GSK Investigational Site, West Palm Beach, Florida 33409, United States

GSK Investigational Site, Atlanta, Georgia 30342, United States

GSK Investigational Site, Savannah, Georgia 31406, United States

GSK Investigational Site, Nampa, Idaho 83686, United States

GSK Investigational Site, Aurora, Illinois 60504, United States

GSK Investigational Site, Chicago, Illinois 60607, United States

GSK Investigational Site, Gillespie, Illinois 62033, United States

GSK Investigational Site, Elkhart, Indiana 46514, United States

GSK Investigational Site, Indianapolis, Indiana 46260, United States

GSK Investigational Site, Indianapolis, Indiana 46250, United States

GSK Investigational Site, Wichita, Kansas 67205, United States

GSK Investigational Site, Wichita, Kansas 67207, United States

GSK Investigational Site, Paducah, Kentucky 42003, United States

GSK Investigational Site, Slidell, Louisiana 70458, United States

GSK Investigational Site, Columbia, Maryland 21045, United States

GSK Investigational Site, Butte, Montana 59701, United States

GSK Investigational Site, Omaha, Nebraska 68134, United States

GSK Investigational Site, Las Vegas, Nevada 89016, United States

GSK Investigational Site, Las Vegas, Nevada 89119, United States

GSK Investigational Site, Albuquerque, New Mexico 87102, United States

GSK Investigational Site, Buffalo, New York 14209, United States

GSK Investigational Site, Buffalo, New York 14215, United States

GSK Investigational Site, East Syracuse, New York 13057, United States

GSK Investigational Site, New York, New York 10075, United States

GSK Investigational Site, Westfield, New York 14787, United States

GSK Investigational Site, Raleigh, North Carolina 27609, United States

GSK Investigational Site, Fargo, North Dakota 58103, United States

GSK Investigational Site, Cincinnati, Ohio 45219, United States

GSK Investigational Site, Corvallis, Oregon 97330, United States

GSK Investigational Site, Altoona, Pennsylvania 16602, United States

GSK Investigational Site, Havertown, Pennsylvania 19083, United States

GSK Investigational Site, Jersey Shore, Pennsylvania 17740, United States

GSK Investigational Site, Lansdale, Pennsylvania 19446, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19154, United States

GSK Investigational Site, Columbia, South Carolina 29201, United States

GSK Investigational Site, Columbia, South Carolina 29204, United States

GSK Investigational Site, Manning, South Carolina 29102, United States

GSK Investigational Site, Johnson City, Tennessee 37601, United States

GSK Investigational Site, Austin, Texas 78705, United States

GSK Investigational Site, Georgetown, Texas 78626, United States

GSK Investigational Site, Grand Prairie, Texas 75052, United States

GSK Investigational Site, Houston, Texas 77081, United States

GSK Investigational Site, San Antonio, Texas 78224, United States

GSK Investigational Site, San Antonio, Texas 78229, United States

GSK Investigational Site, Sugar Land, Texas 77479, United States

GSK Investigational Site, Draper, Utah 84020, United States

GSK Investigational Site, Magna, Utah 84044, United States

GSK Investigational Site, Salt Lake City, Utah 84109, United States

GSK Investigational Site, Salt Lake City, Utah 84121, United States

GSK Investigational Site, Sandy, Utah 84094, United States

GSK Investigational Site, Bellingham/Washington, Washington 98226, United States

GSK Investigational Site, Gig Harbor, Washington 98335, United States

GSK Investigational Site, Olympia, Washington 98502-8151, United States

GSK Investigational Site, Tacoma, Washington 98405, United States

GSK Investigational Site, Beloit, Wisconsin 53511, United States

Additional Information

Related publications:

GSK has submitted manuscripts of these study results to peer-reviewed scientific journals which were not accepted for publication. GSK is providing the attached study results summary with a conclusion.

Starting date: March 2008
Last updated: February 7, 2013

Page last updated: August 23, 2015

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