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HypertensionPhase 3NCT00347360

The COREG And Lisinopril Combination Therapy In Hypertensive Subjects (COSMOS) Trial

A Phase 3 study testing lisinopril in people with Hypertension, run by GlaxoSmithKline at 151 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized, double-blind, double-dummy, parallel group trial employing 15 cells of a 4x4 factorial design (no placebo)to compare the hypertensive effects in patients with Stage 1 and Stage 2 hypertension of carvedilol (20, 40 or 80 mg daily) alone, lisinopril (10, 20 or 40 mg daily) alone, and all… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
lisinopril
Could I receive a placebo?
No, everyone receives an active treatment
How many people
654 participants
Where
151 sitesUnited States
Study dates
Jul 2006to Apr 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has given signed informed consent.
  • Subject is male or female 18 years of age at the time informed consent is signed.
  • At the Screening visit, subject has a documented history or current presentation with stage 1 or stage 2 hypertension (see Section 15.1, Appendix 1 and Section 15.4, Appendix 4) which meets one of the following criteria. Note: All blood pressures are mean sitting cuff pressures:
  • Documented history of hypertension and receiving two antihypertensive medications with mean sDBP <90 mmHg or for diabetic subjects (defined as having an established diagnosis of diabetes or receiving treatment for diabetes), mean sDBP <80 mmHg. Subjects taking beta blockers, clonidine, or other antihypertensive medications where abrupt discontinuation would be of clinical concern must be tapered off the medication during the Washout/Placebo Run-in phase to avoid rebound hypertension. All subjects must be able to be safely withdrawn from all antihypertensive treatment during the Washout/Placebo Run-in phase. Subjects should not be enrolled if the investigator thinks it is likely the subject's mean sDBP will exceed 109 mmHg or their mean sSBP will exceed 180 mmHg during the Washout/Placebo Run-in phase (NOTE: A combination drug containing two antihypertensive agents represents two antihypertensive medications [e.g., Hyzaar is losartan potassium AND hydrochlorothiazide, therefore, counts as two antihypertensive medications].) OR Receiving one antihypertensive medication with mean sDBP =109 mmHg and can be safely withdrawn from all antihypertensive medication during the Washout/Placebo Run-in phase. Any subject who is receiving beta-blockers, clonidine, or other antihypertensive medications where abrupt discontinuation would be of clinical concern must have the dose tapered down during the Washout/Placebo Run-in phase to avoid rebound hypertension. All subjects must be able to be safely withdrawn from all antihypertensive treatment during the Washout/Placebo Run-in phase. Subjects should not be enrolled if the investigator thinks it is likely the subject's mean sDBP will exceed 109 mmHg or their mean sSBP will exceed 180 mmHg during the Washout/Placebo Run-in phase.
  • (NOTE: A combination drug containing two antihypertensive agents represents two antihypertensive medications [e.g., Hyzaar is losartan potassium AND hydrochlorothiazide, therefore, counts as two antihypertensive medications].
  • OR Untreated/newly diagnosed subjects: mean sDBP =95 and =109, or for diabetic subjects, mean sDBP =85 and =109 (see Section 15.1, Appendix 1). If newly diagnosed, must have qualifying blood pressure confirmed on two consecutive visits with the mean sDBP value not differing more than 8 mmHg. (Previously untreated subjects include subjects who have not been treated for hypertension in the last two months.).
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  • At Baseline:
  • DAY BEFORE RANDOMIZATION: Prior to having the baseline ABPM equipment placed, subject has mean sitting cuff DBP that is ≥93 and ≤111 mmHg (or for diabetic subjects, ≥83 and ≤111 mmHg). Subjects who were taking antihypertensive medication at Screening and do not meet this criterion after one week (or 5 half-lives, whichever is longer), can return in one week ±1day and have his/her blood pressure evaluated again for this inclusion criterion.
  • AND
  • RANDOMIZATON DAY: After completion of the ABPM assessment, subject meets the following ABPM (both 12 hr and 24 hr) criteria (see Section 15.1, Appendix 1):
  • Mean 12-hour daytime (9 AM to 9 PM) DBP ≥90 and ≤109mmHg (or for diabetic subjects, ≥80 and ≤109mmHg)
  • At least 75% of the programmed readings properly recorded over 24-hour monitoring period
  • No more than two non-consecutive hours with less than two successful readings per hour while awake, and no more than two consecutive hours with less than one successful reading per hour during the sleep period over the 24-hour monitoring period
  • At least two successful readings per hour for three of the last four hours of recording (trough period i.e., 20-24 hour during which subjects must be awake) with a total of at least 7 successful readings over this period.

Who cannot join

  • Subject is taking ≥3 antihypertensive medications. (NOTE: A combination drug containing two antihypertensive agents represents two antihypertensive medications [e.g., Hyzaar is losartan potassium AND hydrochlorothiazide, therefore, counts as two antihypertensive medications].)
  • Subject has DBP =90 mmHg (or for diabetic subjects, DBP =80 mmHg) on two antihypertensive medications.
  • Subject has any known contraindication to ACE inhibitors (e.g., ACE-induced cough, angioedema or negative renal effects), or blocker treatment.
  • Hyperkalemia or history of hyperkalemia resulting from either Type IV RTA (renal tubular acidosis) or previous ACEi therapy.
  • Is female of childbearing potential. NOTE: Female subjects who are postmenopausal (i.e., no menstrual period for a minimum of 12 months prior to Screening) or surgically sterilized are eligible for the study. If judged appropriate, a postmenopausal woman may be required to have a documented negative urine pregnancy test.
  • Subject has malignant (accelerated) hypertension, history of malignant hypertension, or secondary forms of hypertension.
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  • Subject has mean sitting SBP =180 mmHg.
  • Subject has advanced hypertensive retinopathy (Keith Wagner Grade IV).
  • Subject has Type 1 diabetes mellitus, or those with Type 2 having HbA1c ≥9% at Screening.
  • Subject has uncorrected primary obstructive or severe regurgitative valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathies.
  • Subject has any of the following conditions:
  • uncontrollable or symptomatic arrhythmias unstable angina or angina treated with a beta-blocker sick sinus syndrome or second or third degree heart block (unless treated with a permanent, functioning pacemaker) bradycardia (sitting heart rate <55 bpm) history of myocardial infarction stroke within 3 months of Screening
  • Subject is in atrial fibrillation.
  • Subject has Congestive Heart Failure NYHA (New York Heart Association) class II-IV [The Criteria Committee of the New York Heart Association, 1994].
  • Current clinical evidence of asthma or chronic obstructive pulmonary disease (e.g., severe emphysema or chronic bronchitis) requiring long term use of inhaled oral bronchodilator or steroid drug therapy; also subjects with a history of bronchospastic disease not undergoing active therapy in whom, in the investigator's opinion, treatment with the study medication could provoke bronchospasm; or requirement for or anticipated treatment with beta-2 agonist therapy (e.g., albuterol [Ventolin, Proventil], metaproterenol [Alupent], pirbuterol [Maxair], terbutaline [Brethaire], isoetharine [Bronkosol], and Levalbuterol [Xopenex]).
  • Subject has evidence of any of the following clinically significant diseases that could impair the absorption, metabolism, or excretion of orally-administered medication:
  • renal disease defined as estimated Glomerular Filtration Rate (eGFR) <30mL/min per 1.73 m2 hepatic disease (i.e., ALT or AST levels greater than three times the upper limit of normal range, history of hepatic impairment, or by clinical assessment) chronic biliary disorders gastric bypass surgery
  • Subject has endocrine disorders that affect blood pressure (e.g., pheochromocytoma, active and untreated hypo- or hyperthyroidism).
  • Subject has systemic disease, including cancer, with reduced (<12 months) life expectancy.
  • Subject has used an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding Screening.
  • Subject has a history of a psychological illness/condition that would interfere with their ability to understand or complete the requirements of the study.
  • Subject has any condition that, in the opinion of the Investigator and/or the GSK Medical Monitor, places the subject at an unacceptable risk as a participant in this trial.
  • Subject is receiving ongoing treatment or is anticipated to receive treatment with any of the following medications during treatment with double blind study medication:
  • any antihypertensive medication except for assigned study medication. This would include alpha blockers or other medications that may be used to treat hypertension and other conditions unrelated to hypertension; monoamine oxidase (MAO) inhibitors; any Class I or III antiarrhythmic; beta-2-agonists.

Trial locations and contacts

151 sites in 1 country.

151 sites in 1 country

United States151 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87102

  • GSK Investigational Site

    Ames, Iowa, 50010

  • GSK Investigational Site

    Anniston, Alabama, 36207

  • GSK Investigational Site

    Arlington, Texas, 76014

  • GSK Investigational Site

    Arlington, Virginia, 22205

  • GSK Investigational Site

    Asheville, North Carolina, 28801

  • GSK Investigational Site

    Aurora, Illinois, 60504

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Avon, Indiana, 46123

  • GSK Investigational Site

    Beaufort, South Carolina, 29906

  • GSK Investigational Site

    Beaver, Pennsylvania, 15009

  • GSK Investigational Site

    Beuna Park, California, 90620

  • GSK Investigational Site

    Beverly Hills, California, 90211

  • GSK Investigational Site

    Bingham Farms, Michigan, 48025

  • GSK Investigational Site

    Birmingham, Alabama, 35215

  • GSK Investigational Site

    Birmingham, Alabama, 35216

  • GSK Investigational Site

    Birmingham, Alabama, 35235

  • GSK Investigational Site

    Birmingham, Alabama, 35242

  • GSK Investigational Site

    Bloomington, Indiana, 47102

  • GSK Investigational Site

    Brooklyn, New York, 11203

  • GSK Investigational Site

    Brooklyn Center, Minnesota, 55430

  • GSK Investigational Site

    Buffalo, New York, 14215

  • GSK Investigational Site

    Burbank, California, 91505

  • GSK Investigational Site

    Burke, Virginia, 22015

  • GSK Investigational Site

    Carlsbad, California, 92008

  • GSK Investigational Site

    Chandler, Arizona, 85225

  • GSK Investigational Site

    Charleston, South Carolina, 29403

  • GSK Investigational Site

    Charlotte, North Carolina, 28211

  • GSK Investigational Site

    Cherry Hill, New Jersey, 08034

  • GSK Investigational Site

    Chester, Virginia, 23836

  • GSK Investigational Site

    Chicago, Illinois, 60607

  • GSK Investigational Site

    Chicago, Illinois, 60610

  • GSK Investigational Site

    Cincinnati, Ohio, 45219

  • GSK Investigational Site

    Cincinnati, Ohio, 45236

  • GSK Investigational Site

    Clarksville, Tennessee, 37043

  • GSK Investigational Site

    Cleveland, Ohio, 44106

  • GSK Investigational Site

    Cleveland, Ohio, 44195

  • GSK Investigational Site

    Colorado Springs, Colorado, 80904

  • GSK Investigational Site

    Columbia, South Carolina, 29201

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Dayton, Ohio, 45406

  • GSK Investigational Site

    Denver, Colorado, 80206

  • GSK Investigational Site

    Doylestown, Pennsylvania, 18901

  • GSK Investigational Site

    Edison, New Jersey, 08817

  • GSK Investigational Site

    Erie, Pennsylvania, 16504

  • GSK Investigational Site

    Eugene, Oregon, 97401

  • GSK Investigational Site

    Fairfax, Virginia, 22030

  • GSK Investigational Site

    Fargo, North Dakota, 58103

  • GSK Investigational Site

    Fort Wayne, Indiana, 46804

  • GSK Investigational Site

    Fountain Valley, California, 92708

  • GSK Investigational Site

    Fresno, California, 93703

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Gainesville, Georgia, 30501

  • GSK Investigational Site

    Georgetown, Texas, 78626

  • GSK Investigational Site

    Gilbert, Arizona, 85296

  • GSK Investigational Site

    Glendale, Arizona, 85308

  • GSK Investigational Site

    Grand Prairie/Texas, Texas, 5052

  • GSK Investigational Site

    Greer, South Carolina, 29651

  • GSK Investigational Site

    Haleyville, Alabama, 35565

  • GSK Investigational Site

    Havertown, Pennsylvania, 19083

  • GSK Investigational Site

    Hialeah, Florida, 33013

  • GSK Investigational Site

    High Point, North Carolina, 27262

  • GSK Investigational Site

    Hilton Head Island, South Carolina, 29926

  • GSK Investigational Site

    Hollywood, Florida, 33023

  • GSK Investigational Site

    Houston, Texas, 77081

  • GSK Investigational Site

    Indianapolis, Indiana, 46250

  • GSK Investigational Site

    Jackson, Tennessee, 38305

  • GSK Investigational Site

    Jacksonville, Florida, 32205

  • GSK Investigational Site

    Jacksonville Beach, Florida, 32250

  • GSK Investigational Site

    Johnson City, Tennessee, 37601

  • GSK Investigational Site

    Kingston, New York, 12401

  • GSK Investigational Site

    Landsdale, Pennsylvania, 19446

  • GSK Investigational Site

    Las Vegas, Nevada, 89016

  • GSK Investigational Site

    Las Vegas, Nevada, 89119

  • GSK Investigational Site

    Las Vegas, Nevada, 89128

  • GSK Investigational Site

    Leetsdale, Pennsylvania, 15056

  • GSK Investigational Site

    Lewinston, New York, 14092

  • GSK Investigational Site

    Little Rock, Arkansas, 72204

  • GSK Investigational Site

    Loma Linda, California, 92354

  • GSK Investigational Site

    Longview, Texas, 75605

  • GSK Investigational Site

    Manassas, Virginia, 20110

  • GSK Investigational Site

    Manning, South Carolina, 29102

  • GSK Investigational Site

    Marietta, Georgia, 30066

  • GSK Investigational Site

    Melrose Park, Illinois, 60160

  • GSK Investigational Site

    Mesa, Arizona, 85206

  • GSK Investigational Site

    Miami, Florida, 33156

  • GSK Investigational Site

    Miami, Florida, 33169

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53209

  • GSK Investigational Site

    Mission Viejo, California, 92691

  • GSK Investigational Site

    Missoula, Montana, 59808

  • GSK Investigational Site

    Mobile, Alabama, 36617

  • GSK Investigational Site

    Murray, Utah, 84107

  • GSK Investigational Site

    Muscle Shoals, Alabama, 35662

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    O Fallon, Montana, 63366

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73103

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Omaha, Nebraska, 68131

  • GSK Investigational Site

    Palm Harbor, Florida, 34684

  • GSK Investigational Site

    Pembroke Pines, Florida, 33024

  • GSK Investigational Site

    Pembroke Pines, Florida, 33027

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19152

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19154

  • GSK Investigational Site

    Phoenix, Arizona, 85023

  • GSK Investigational Site

    Phoenix, Arizona, 85032

  • GSK Investigational Site

    Phoenix, Arizona, Arizona, 86106

  • GSK Investigational Site

    Pico Rivera, California, 90660

  • GSK Investigational Site

    Raleigh, North Carolina, 27615

  • GSK Investigational Site

    Rancho Cordova, California, 95670

  • GSK Investigational Site

    Ridgewood, New Jersey, 7450

  • GSK Investigational Site

    Salt Lake City, Utah, 84102

  • GSK Investigational Site

    San Antonio, Texas, 78224

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 92117

  • GSK Investigational Site

    San Diego, California, 92128

  • GSK Investigational Site

    Sandersville, Georgia, 31082

  • GSK Investigational Site

    Sandy City, Utah, 84094

  • GSK Investigational Site

    Santa Ana, California, 92705

  • GSK Investigational Site

    Sarasota, Florida, 34239

  • GSK Investigational Site

    Savannah, Georgia, 31406

  • GSK Investigational Site

    Scottsdale, Arizona, 85251

  • GSK Investigational Site

    Scottsdale, Arizona, 85260

  • GSK Investigational Site

    Searcy, Arkansas, 72143

  • GSK Investigational Site

    Selmer, Tennessee, 38375

  • GSK Investigational Site

    Simpsonville, South Carolina, 29681

  • GSK Investigational Site

    Slidell, Louisiana, 70458

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Spokane, Washington, 99206

  • GSK Investigational Site

    Springfield, Massachusetts, 01103

  • GSK Investigational Site

    Sugar Land, Texas, 77479

  • GSK Investigational Site

    Sumter, South Carolina, 29150

  • GSK Investigational Site

    Sun City, Arizona, 85351

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Taunton, Massachusetts, 02780.

  • GSK Investigational Site

    Taylors, South Carolina, 29687

  • GSK Investigational Site

    Temple, Texas, 76502

  • GSK Investigational Site

    Tonawanda, New York, 14150-1810

  • GSK Investigational Site

    Tucson, Arizona, 85712

  • GSK Investigational Site

    Tucson, Arizona, 85741

  • GSK Investigational Site

    Tulsa, Oklahoma, 74104

  • GSK Investigational Site

    Union, South Carolina, 29309

  • GSK Investigational Site

    Vista, California, 92084

  • GSK Investigational Site

    Voorhees Township, New Jersey, 08043

  • GSK Investigational Site

    Waco, Texas, 76712

  • GSK Investigational Site

    Walnut Creek, California, 94598

  • GSK Investigational Site

    Warminster, Pennsylvania, 18974

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20017

  • GSK Investigational Site

    West Chester, Pennsylvania, 19380

  • GSK Investigational Site

    West Palm Beach, Florida, 33409

  • GSK Investigational Site

    Wichita, Kansas, 67205

  • GSK Investigational Site

    Wilmington, Delaware, 19805

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Double-Dummy, Parallel Group, Factorial Design Trial to Assess the Efficacy and Safety of up to Six Weeks Treatment With 20mg, 40mg, or 80mg QD Doses of Carvedilol Controlled Release Formulation (COREG CR) or 10mg, 20mg, or 40mg QD Doses of Lisinopril (Zestril) or a Combination of One of the Doses of Each Medication

This is a randomized, double-blind, double-dummy, parallel group trial employing 15 cells of a 4x4 factorial design (no placebo)to compare the hypertensive effects in patients with Stage 1 and Stage 2 hypertension of carvedilol (20, 40 or 80 mg daily) alone, lisinopril (10, 20 or 40 mg daily) alone, and all combinations of the doses.

Read the detailed description

A Randomized, Double-Blind, Double-Dummy, Parallel Group, Factorial Design Trial to Assess the Efficacy and Safety of up to Six Weeks Treatment with 20mg, 40mg, or 80mg QD Doses of Carvedilol Controlled Release Formulation (COREG CR) or 10mg, 20mg, or 40mg QD Doses of Lisinopril (ZESTRIL) or a Combination of One of the Doses of Each Medication

Conditions
Hypertension
Being tested
lisinopril, carvedilol controlled release formulation
Keywords
carvedilol, hypertension, lisinopril, factorial
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lisinoprilDrug

  • carvedilol controlled release formulationDrug

    Also called lisinopril

Study groups in NCT00347360
Study groupRoleWhat they receive
lisinoprilExperimentallisinopril
Receives: Drug: lisinopril
carvedilolExperimentalcarvedilol controlled release formulation
Receives: Drug: carvedilol controlled release formulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure

    Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean diastolic blood pressure (DBP).

    Measured: Baseline, Week 6.

  2. Change From Baseline to Week 6 in Trough Diastolic Blood Pressure

    Trough ABPM was the average across 20-24 hr after dosing for each subject.

    Measured: Baseline, Week 6

Secondary outcomes (10)

  1. Change From Baseline to Week 6 in 24 Hour Mean Systolic Blood Pressure

    Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean systolic blood pressure (SBP).

    Measured: Baseline, Week 6

  2. Change From Baseline to Week 6 in Trough Systolic Blood Pressure

    Trough ABPM was the average across 20-24 hr after dosing for each subject.

    Measured: Baseline, Week 6

  3. Dose-response Treatment Estimates: Change From Baseline to Week 6 in 24 Hour Mean DBP by ABPM (Ambulatory Blood Pressure Monitoring)

    Evaluation of the dose-response relationship between incremental doses of carvedilol CR and lisinopril and mean 24-hr ABPM DBP.

    Measured: Baseline, Week 6

  4. Change From Baseline to Week 6 in Trough to Peak Ratios of DBP by 24 Hour ABPM (Ambulatory Blood Pressure Monitoring)

    Trough (20-24 hr) to peak (3-7 hr) ratios of DBP were examined in order to evaluate the extent to which once-daily criteria were met (ie trough:peak > 50%). Trough to peak ratios were calculated from change trough mean/change peak mean x 100.

    Measured: Baseline, Week 6

  5. Overall Description of Safety in Each Treatment Group Using Adverse Events, Laboratory Evaluations, ECG Changes, Vital Sign Changes, and Withdrawal Rates.

    Refer to Adverse Event section for safety information.

    Measured: Weeks 1 through 48

  6. Change From Baseline to Week 6 in Mean SBP and DBP Measured in Morning by 24 Hour ABPM

    Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the morning. The morning assessment period started at or after 6 am and ended immediately before 12 noon.

    Measured: Morning BP, Baseline, Week 6

  7. Change From Baseline to Week 6 in Mean SBP and DBP Measured in Afternoon by 24hr ABPM

    Mean changes from Baseline to Week 6 in SBP and DBP measured by 24hr ABPM at the end of up-titration recorded in the afternoon. The afternoon assessment period started at or after 12 noon and ended immediately before 6 pm.

    Measured: Afternoon BP, Baseline, Week 6

  8. Change From Baseline to Week 6 in Mean SBP and DBP Measured at Night by 24hr ABPM

    Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the night. The night-time assessment period started at the time of the first reading at or after 6 pm and ended immediately before 6 am on the following day.

    Measured: Night BP, Baseline, Week 6

  9. Change From Baseline to Week 6 in Mean Trough Sitting SBP and Sitting DBP by Cuff Assessment

    Analysis of Change from Baseline to Week 6 in Mean sSBP and sDBP by Cuff Assessments at Drug Trough (20-24 hr) at End of Treatment Titration

    Measured: Baseline, Week 6

  10. Diastolic Responders, Defined as ≥ 10 mmHg Sitting (s)DBP Reduction From Baseline or a sDBP of <90 / 80 Millimeters (mm) of Mercury (Hg) for Non Diabetic / Diabetic Subjects Respectively (Based on Cuff Trough Measures)

    Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
654 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00347360
Sponsor's protocol ID
CFD105453
Status last verified
Nov 2016
First submitted
29 Jun 2006
Last updated
26 Dec 2016
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Bakris GL, Iyengar M, Lukas MA, Ordronneau P, Weber MA. Effect of combining extended-release carvedilol and lisinopril in hypertension: results of the COSMOS study. J Clin Hypertens (Greenwich). 2010 Sep;12(9):678-86. doi: 10.1111/j.1751-7176.2010.00341.x. Epub 2010 Jul 8.

    PubMed 20883227

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lisinopril in people with Hypertension, run by GlaxoSmithKline at 151 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure (time frame: Baseline, Week 6.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00347360, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2016.

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