Trial · NCT00347360
The COREG And Lisinopril Combination Therapy In Hypertensive Subjects (COSMOS) Trial
NCT00347360, Phase 3, Completed, GlaxoSmithKline; results first posted 2009-11-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The COREG And Lisinopril Combination Therapy In Hypertensive Subjects (COSMOS) Trial. Trials, record NCT00347360. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00347360
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The COREG And Lisinopril Combination Therapy In Hypertensive Subjects (COSMOS) Trial
- NCT number
- NCT00347360
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 654 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hypertension
- Interventions
- lisinopril, carvedilol controlled release formulation
- First posted
- 2006-07-04
- Last updated
- 2016-12-26
- Results first posted
- 2009-11-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure | Baseline, Week 6. | 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). |
| Primary | Change From Baseline to Week 6 in Trough Diastolic Blood Pressure | Baseline, Week 6 | Trough ABPM was the average across 20-24 hr after dosing for each subject. |
| Secondary | Change From Baseline to Week 6 in 24 Hour Mean Systolic Blood Pressure | Baseline, Week 6 | 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). |
| Secondary | Change From Baseline to Week 6 in Trough Systolic Blood Pressure | Baseline, Week 6 | Trough ABPM was the average across 20-24 hr after dosing for each subject. |
| Secondary | Dose-response Treatment Estimates: Change From Baseline to Week 6 in 24 Hour Mean DBP by ABPM (Ambulatory Blood Pressure Monitoring) | Baseline, Week 6 | Evaluation of the dose-response relationship between incremental doses of carvedilol CR and lisinopril and mean 24-hr ABPM DBP. |
| Secondary | Change From Baseline to Week 6 in Trough to Peak Ratios of DBP by 24 Hour ABPM (Ambulatory Blood Pressure Monitoring) | Baseline, Week 6 | 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. |
| Secondary | Overall Description of Safety in Each Treatment Group Using Adverse Events, Laboratory Evaluations, ECG Changes, Vital Sign Changes, and Withdrawal Rates. | Weeks 1 through 48 | Refer to Adverse Event section for safety information. |
| Secondary | Change From Baseline to Week 6 in Mean SBP and DBP Measured in Morning by 24 Hour ABPM | Morning BP, Baseline, Week 6 | 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. |
| Secondary | Change From Baseline to Week 6 in Mean SBP and DBP Measured in Afternoon by 24hr ABPM | Afternoon BP, Baseline, Week 6 | 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. |
| Secondary | Change From Baseline to Week 6 in Mean SBP and DBP Measured at Night by 24hr ABPM | Night BP, Baseline, Week 6 | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure | Baseline, Week 6. | ABPM Population with Last Observation Carried Forward (LOCF): This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population. | mmHg | MEAN |
| PRIMARY | Change From Baseline to Week 6 in Trough Diastolic Blood Pressure | Baseline, Week 6 | ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population | mmHg | MEAN |
| SECONDARY | Change From Baseline to Week 6 in 24 Hour Mean Systolic Blood Pressure | Baseline, Week 6 | ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population | mmHg | MEAN |
| SECONDARY | Change From Baseline to Week 6 in Trough Systolic Blood Pressure | Baseline, Week 6 | ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population | mmHg | MEAN |
| SECONDARY | Dose-response Treatment Estimates: Change From Baseline to Week 6 in 24 Hour Mean DBP by ABPM (Ambulatory Blood Pressure Monitoring) | Baseline, Week 6 | ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population | mmHg | MEAN |
| SECONDARY | Change From Baseline to Week 6 in Trough to Peak Ratios of DBP by 24 Hour ABPM (Ambulatory Blood Pressure Monitoring) | Baseline, Week 6 | ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population | trough:peak ratio x 100% | NUMBER |
| SECONDARY | Overall Description of Safety in Each Treatment Group Using Adverse Events, Laboratory Evaluations, ECG Changes, Vital Sign Changes, and Withdrawal Rates. | Weeks 1 through 48 | |||
| SECONDARY | Change From Baseline to Week 6 in Mean SBP and DBP Measured in Morning by 24 Hour ABPM | Morning BP, Baseline, Week 6 | ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population | mmHg | MEAN |
| SECONDARY | Change From Baseline to Week 6 in Mean SBP and DBP Measured in Afternoon by 24hr ABPM | Afternoon BP, Baseline, Week 6 | ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population | mmHg | MEAN |
| SECONDARY | Change From Baseline to Week 6 in Mean SBP and DBP Measured at Night by 24hr ABPM | Night BP, Baseline, Week 6 | : ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population | mmHg | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group225
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure | Lisinopril 10 | -5.79 | Standard Deviation 5.922 | mmHg | |
| Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure | Lisinopril 20 | -8.11 | Standard Deviation 8.811 | mmHg | |
| Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure | Lisinopril 40 | -7.37 | Standard Deviation 5.914 | mmHg | |
| Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure | Carvedilol Controlled Release 20 | -4.40 | Standard Deviation 5.182 | mmHg | |
| Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure | Carvedilol Controlled Release 40 | -7.61 | Standard Deviation 4.880 | mmHg | |
| Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure | Carvedilol Controlled Release 80 | -6.52 | Standard Deviation 6.408 | mmHg | |
| Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure | Carvedilol Controlled Release 20 Lisinopril 10 | -9.29 | Standard Deviation 7.226 | mmHg | |
| Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure | Carvedilol Controlled Release 20 Lisinopril 20 | -8.57 | Standard Deviation 6.585 | mmHg | |
| Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure | Carvedilol Controlled Release 20 Lisinopril 40 | -10.19 | Standard Deviation 6.899 | mmHg | |
| Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure | Carvedilol Controlled Release 40 Lisinopril 10 | -9.36 | Standard Deviation 7.426 | mmHg |
1 to 10 of 225Source ClinicalTrials.gov
See all 225 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lisinopril 10 | 44 | |
| Overall Study | STARTED | Lisinopril 20 | 43 | |
| Overall Study | STARTED | Lisinopril 40 | 43 | |
| Overall Study | STARTED | Carvedilol Controlled Release 20 | 43 | |
| Overall Study | STARTED | Carvedilol Controlled Release 40 | 44 | |
| Overall Study | STARTED | Carvedilol Controlled Release 80 | 44 | |
| Overall Study | STARTED | Carvedilol Controlled Release 20 Lisinopril 10 | 44 | |
| Overall Study | STARTED | Carvedilol Controlled Release 20 Lisinopril 20 | 43 | |
| Overall Study | STARTED | Carvedilol Controlled Release 20 Lisinopril 40 | 44 | |
| Overall Study | STARTED | Carvedilol Controlled Release 40 Lisinopril 10 | 44 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events570
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Lisinopril 10 | 4 | 44 | |
| other | Headache | Nervous system disorders | Lisinopril 20 | 1 | 42 | |
| other | Headache | Nervous system disorders | Lisinopril 40 | 7 | 43 | |
| other | Headache | Nervous system disorders | Carvedilol Controlled Release 20 | 7 | 43 | |
| other | Headache | Nervous system disorders | Carvedilol Controlled Release 40 | 5 | 43 | |
| other | Headache | Nervous system disorders | Carvedilol Controlled Release 80 | 4 | 44 | |
| other | Headache | Nervous system disorders | Carvedilol Controlled Release 20 Lisinopril 10 | 4 | 44 | |
| other | Headache | Nervous system disorders | Carvedilol Controlled Release 20 Lisinopril 20 | 4 | 43 | |
| other | Headache | Nervous system disorders | Carvedilol Controlled Release 20 Lisinopril 40 | 5 | 44 | |
| other | Headache | Nervous system disorders | Carvedilol Controlled Release 40 Lisinopril 10 | 3 | 44 |
1 to 10 of 570Source ClinicalTrials.gov
See all 570 adverse eventsAdverse event totals45
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lisinopril 10 | ||
| Total, all-cause mortality | Lisinopril 20 | ||
| Total, all-cause mortality | Lisinopril 40 | ||
| Total, all-cause mortality | Carvedilol Controlled Release 20 | ||
| Total, all-cause mortality | Carvedilol Controlled Release 40 | ||
| Total, all-cause mortality | Carvedilol Controlled Release 80 | ||
| Total, all-cause mortality | Carvedilol Controlled Release 20 Lisinopril 10 | ||
| Total, all-cause mortality | Carvedilol Controlled Release 20 Lisinopril 20 | ||
| Total, all-cause mortality | Carvedilol Controlled Release 20 Lisinopril 40 | ||
| Total, all-cause mortality | Carvedilol Controlled Release 40 Lisinopril 10 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20883227 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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