Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)
NCT01096667
Last updated date
ABOUT THIS STUDY
MK-8835-042 (B1521004) is designed to assess the safety and efficacy of an investigational
drug, ertugliflozin (MK-8835, PF-04971729), in participants with type 2 diabetes and
hypertension. Participants in the study will receive 1 of 5 treatments for 28 days (either
placebo, 1 of 3 doses of ertugliflozin [1, 5, or 25 mg], or the approved drug
hydrochlorothiazide [HCTZ]). The primary hypothesis of the study was that ertugliflozin was
superior to placebo on the change from baseline in average, 24-hour systolic blood pressure
(SBP) on Day 28.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus, Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Participants with type 2 diabetes and hypertension
- Medically stable
- On at least 1 (and up to 2) oral diabetes drugs
- And up to 2 medicines for blood pressure control
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Participants with type 1 diabetes
- Heart attack
- Stroke
- Uncontrolled blood pressure
- Significant kidney disease
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Type 2 Diabetes Mellitus, HypertensionStudy of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)
NCT01096667
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042) | ||||||
| Official Title ICMJE | A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate The Safety, Tolerability And Efficacy Of Once Daily PF-04971729 And Hydrochlorothiazide In Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic And Blood Pressure Control | ||||||
| Brief Summary | MK-8835-042 (B1521004) is designed to assess the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729), in participants with type 2 diabetes and hypertension. Participants in the study will receive 1 of 5 treatments for 28 days (either placebo, 1 of 3 doses of ertugliflozin [1, 5, or 25 mg], or the approved drug hydrochlorothiazide [HCTZ]). The primary hypothesis of the study was that ertugliflozin was superior to placebo on the change from baseline in average, 24-hour systolic blood pressure (SBP) on Day 28. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | ||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Amin NB, Wang X, Mitchell JR, Lee DS, Nucci G, Rusnak JM. Blood pressure-lowering effect of the sodium glucose co-transporter-2 inhibitor ertugliflozin, assessed via ambulatory blood pressure monitoring in patients with type 2 diabetes and hypertension. Diabetes Obes Metab. 2015 Aug;17(8):805-8. doi: 10.1111/dom.12486. Epub 2015 Jun 17. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 194 | ||||||
| Original Estimated Enrollment ICMJE | 175 | ||||||
| Actual Study Completion Date ICMJE | February 25, 2011 | ||||||
| Actual Primary Completion Date | February 9, 2011 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Not Provided | ||||||
| Removed Location Countries | India, Malaysia, Puerto Rico, Serbia, Taiwan, United States | ||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT01096667 | ||||||
| Other Study ID Numbers ICMJE | 8835-042 B1521004 ( Other Identifier: Pfizer protocol number ) MK-8835-042 ( Other Identifier: Merck Protocol Number ) | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
| ||||||
| IPD Sharing Statement ICMJE |
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| Responsible Party | Merck Sharp & Dohme Corp. | ||||||
| Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||||||
| Collaborators ICMJE | Pfizer | ||||||
| Investigators ICMJE |
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| PRS Account | Merck Sharp & Dohme Corp. | ||||||
| Verification Date | August 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||