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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
Clinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
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 |
| ||||||
| Intervention ICMJE |
| ||||||
| Study Arms ICMJE |
| ||||||
| 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 |
| ||||||
| Responsible Party | Merck Sharp & Dohme Corp. | ||||||
| Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||||||
| Collaborators ICMJE | Pfizer | ||||||
| Investigators ICMJE |
| ||||||
| 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 | |||||||