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Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)

NCT01096667 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2018-09-13

Study results available
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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.

Conditions

Interventions

DRUG

Placebo to Ertuglilflozin 1 or 5 mg

Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days

DRUG

Ertugliflozin 1 mg

Ertugliflozin tablet 1 mg once daily for 28 days

DRUG

Ertugliflozin 5 mg

Ertugliflozin tablet 5 mg once daily for 28 days

DRUG

Ertugliflozin 25 mg

Ertugliflozin tablet 25 mg once daily for 28 days

DRUG

HCTZ 12.5mg

Hydrocholorthiazide (HCTZ) 12.5 mg capsule once daily for 28 days

DRUG

Placebo to HCTZ

Placebo to HCTZ 12.5 mg capsule once daily for 28 days

DRUG

Placebo to ertuglilflozin 25 mg

Placebo to ertuglilflozin tablet 25 mg once daily for 28 days

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-17
Primary Completion
2011-02-09
Completion
2011-02-25
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01096667 on ClinicalTrials.gov