Trial · NCT00274716
Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)
NCT00274716, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2014-02-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED). Trials, record NCT00274716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00274716
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)
- NCT number
- NCT00274716
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 249 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hypertension
- Interventions
- MK0736, MK0916, Placebo
- First posted
- 2006-01-11
- Last updated
- 2015-07-03
- Results first posted
- 2014-02-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Baseline and Week 12 (end of Phase A) | Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded. |
| Primary | Number of Participants Who Reported a Clinical Adverse Event | 24 weeks | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. |
| Primary | Number of Participants Who Reported a Laboratory Adverse Event | 24 weeks | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. |
| Primary | Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event | 24 weeks | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. |
| Primary | Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event | 24 weeks | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. |
| Secondary | Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Baseline and Week 12 (end of Phase A) | Sitting systolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean trough value of the 3 measurements at the 2 timepoints was recorded. |
| Secondary | Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI | Baseline and Week 12 (end of Phase A) | Weight was measured in duplicate (2 measurements) at baseline and after 12 weeks of study drug administration. The mean of the 2 values at each assessment was used in analysis. |
| Secondary | Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI | Baseline and Week 12 (end of Phase A) | Waist circumference measured in cm at baseline and after 12 weeks of study drug administration |
| Secondary | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Baseline and Week 12 (end of Phase A) | LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration. |
| Secondary | Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI | Baseline and Week 12 (end of Phase A) | HDL-C measured at baseline and after 12 weeks of study drug administration. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Baseline and Week 12 (end of Phase A) | Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint. | mm Hg | MEAN |
| SECONDARY | Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Baseline and Week 12 (end of Phase A) | Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint. | mm Hg | MEAN |
| SECONDARY | Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI | Baseline and Week 12 (end of Phase A) | Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint. | kg | MEAN |
| SECONDARY | Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI | Baseline and Week 12 (end of Phase A) | Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint. | cm | MEAN |
| SECONDARY | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Baseline and Week 12 (end of Phase A) | Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint. | percentage change | MEAN |
| SECONDARY | Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI | Baseline and Week 12 (end of Phase A) | Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Baseline and Week 12 (end of Phase A) | Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint. | Percent change | MEAN |
| PRIMARY | Number of Participants Who Reported a Clinical Adverse Event | 24 weeks | All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy. | Participants | NUMBER |
| PRIMARY | Number of Participants Who Reported a Laboratory Adverse Event | 24 weeks | All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy. | Participants | NUMBER |
| PRIMARY | Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event | 24 weeks | All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy. | Participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | MK-0736 2.0 mg High BMI | -4.2 | Standard Deviation 7.3 | mm Hg | |
| Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | MK-0736 7.0 mg High BMI | -2.4 | Standard Deviation 8.1 | mm Hg | |
| Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | MK-0916 6.0 mg High BMI | -3.1 | Standard Deviation 7.9 | mm Hg | |
| Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Placebo High BMI | -0.2 | Standard Deviation 8.7 | mm Hg | |
| Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | MK-0736 2.0 mg High BMI | -3.5 | Standard Deviation 13.2 | mm Hg | |
| Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | MK-0736 7.0 mg High BMI | -4.2 | Standard Deviation 12.9 | mm Hg | |
| Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | MK-0916 6.0 mg High BMI | -3.2 | Standard Deviation 11.3 | mm Hg | |
| Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Placebo High BMI | 0.7 | Standard Deviation 12.2 | mm Hg | |
| Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI | MK-0736 2.0 mg High BMI | -0.6 | Standard Deviation 1.8 | kg | |
| Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI | MK-0736 7.0 mg High BMI | -0.9 | Standard Deviation 2.0 | kg |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase A | STARTED | High BMI:MK-0736 2mg→Placebo | 54 | |
| Phase A | STARTED | High BMI:MK-0736 7mg→Placebo | 54 | |
| Phase A | STARTED | High BMI:MK-0916 6mg→MK-0916 6mg | 52 | |
| Phase A | STARTED | High BMI:Placebo→Placebo | 51 | |
| Phase A | STARTED | Low BMI:MK-0916 6mg→MK-0916 6mg | 19 | |
| Phase A | STARTED | Low BMI:Placebo→Placebo | 19 | |
| Phase A | COMPLETED | High BMI:MK-0736 2mg→Placebo | 43 | |
| Phase A | COMPLETED | High BMI:MK-0736 7mg→Placebo | 44 | |
| Phase A | COMPLETED | High BMI:MK-0916 6mg→MK-0916 6mg | 44 | |
| Phase A | COMPLETED | High BMI:Placebo→Placebo | 42 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events354
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 | Constipation | Gastrointestinal disorders | High BMI:MK-0736 2mg→Placebo | 3 | 54 | |
| other | Constipation | Gastrointestinal disorders | High BMI:MK-0736 7mg→Placebo | 0 | 54 | |
| other | Constipation | Gastrointestinal disorders | High BMI:MK-0916 6mg→MK-0916 6mg | 3 | 52 | |
| other | Constipation | Gastrointestinal disorders | High BMI:Placebo→Placebo | 2 | 51 | |
| other | Constipation | Gastrointestinal disorders | Low BMI:MK-0916 6mg→MK-0916 6mg | 0 | 19 | |
| other | Constipation | Gastrointestinal disorders | Low BMI:Placebo→Placebo | 0 | 19 | |
| other | Nausea | Gastrointestinal disorders | High BMI:MK-0736 2mg→Placebo | 2 | 54 | |
| other | Nausea | Gastrointestinal disorders | High BMI:MK-0736 7mg→Placebo | 1 | 54 | |
| other | Nausea | Gastrointestinal disorders | High BMI:MK-0916 6mg→MK-0916 6mg | 4 | 52 | |
| other | Nausea | Gastrointestinal disorders | High BMI:Placebo→Placebo | 1 | 51 |
1 to 10 of 354Source ClinicalTrials.gov
See all 354 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High BMI:MK-0736 2mg→Placebo | ||
| Total, all-cause mortality | High BMI:MK-0736 7mg→Placebo | ||
| Total, all-cause mortality | High BMI:MK-0916 6mg→MK-0916 6mg | ||
| Total, all-cause mortality | High BMI:Placebo→Placebo | ||
| Total, all-cause mortality | Low BMI:MK-0916 6mg→MK-0916 6mg | ||
| Total, all-cause mortality | Low BMI:Placebo→Placebo | ||
| Total, other adverse events | High BMI:MK-0736 2mg→Placebo | 40 | 54 |
| Total, other adverse events | High BMI:MK-0736 7mg→Placebo | 39 | 54 |
| Total, other adverse events | High BMI:MK-0916 6mg→MK-0916 6mg | 37 | 52 |
| Total, other adverse events | High BMI:Placebo→Placebo | 37 | 51 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21419745 | 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
Read this trial from software.
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