Study of Safety and Efficacy Of PF-04971729 In Patients With Type 2 Diabetes And Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01096667
First received: March 26, 2010
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

B1521004 is designed to study how safe and how effective is an investigational drug, PF-04971729, in people with type 2 diabetes and hypertension. Patients in the study will receive 1 of 5 treatments for 1 month including 1 treatment with an approved drug - hydrochlorothiazide.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Hypertension
Drug: Placebo
Drug: 1 mg PF-04971729
Drug: 5 mg PF-04971729
Drug: 25 mg PF-04971729
Drug: 12.5mg HCTZ
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Placebo-adjusted, change from baseline on average, 24 hour systolic blood pressure (SBP) on Day 28 assessed using 24 hour ambulatory blood pressure monitoring (ABPM) [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Placebo-adjusted, change from baseline on average, daytime, night time and 24-hour diastolic blood pressure (DBP), and pulse rate on Day 28 using 24 hour ABPM [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Placebo-adjusted, change from baseline on average daytime, night time SBP using 24 hour ABPM [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Placebo-adjusted, change from baseline in trough SBP, DBP and pulse rate using automated device [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Placebo-adjusted, change from baseline on 24 hour urinary glucose excretion on Day 28 [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Placebo adjusted, change from baseline in fasting plasma glucose [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Placebo-adjusted, change from baseline on average, daytime, night time and 24 hour SBP, DBP, pulse rate on Day 28 using 24 hour ABPM [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Assessment of clinical safety-related laboratory tests, 12 lead electrocardiograms (ECG), adverse events/serious adverse events including urinary tract and genital fungal infections, hypo- and hyper- glycemia as well as hypo- and hyper tension [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]

Enrollment: 195
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo for PF-04971729 and HCTZ
Drug: Placebo
Pills (n=3), 0 mg, once daily x 28-days
Experimental: 1 mg PF-04971729
1 mg PF-04971729
Drug: 1 mg PF-04971729
pill (n=1), 1 mg strength + pills (n=2), 0 mg, all once daily x 28-days
Experimental: 5 mg PF-04971729
5 mg PF-04971729
Drug: 5 mg PF-04971729
pill (n=1), 5 mg strength + pills (n=2), 0 mg, all once daily x 28-days
Experimental: 25 mg PF-04971729
25 mg PF-04971729
Drug: 25 mg PF-04971729
pill (n=1), 25 mg strength + pills (n=2), 0 mg, all once daily x 28-days
Active Comparator: 12.5mg HCTZ
12.5mg hydrochlorothiazide (HCTZ)
Drug: 12.5mg HCTZ
pill (n=1), 12.5 mg strength + pills (n=2), 0 mg, all once daily x 28-days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 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:

  • Patients with type 1 diabetes
  • Heart attack
  • Stroke
  • Uncontrolled blood pressure
  • Significant kidney disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096667

  Show 40 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01096667     History of Changes
Other Study ID Numbers: B1521004
Study First Received: March 26, 2010
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
type 2 diabetes
hypertension
ambulatory blood pressure monitoring

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014