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

  Hide Study Locations
Locations
United States, Arizona
Pfizer Investigational Site
Mesa, Arizona, United States, 85206
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
Fresno, California, United States, 93720
Pfizer Investigational Site
Los Angeles, California, United States, 90057
Pfizer Investigational Site
Mission Hills, California, United States, 91345
Pfizer Investigational Site
National City, California, United States, 91950
Pfizer Investigational Site
Porter Ranch, California, United States, 91326
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60606
Pfizer Investigational Site
Chicago, Illinois, United States, 60607
United States, Massachusetts
Pfizer Investigational Site
Brockton, Massachusetts, United States, 02301
United States, Mississippi
Pfizer Investigational Site
Jackson, Mississippi, United States, 39216
United States, North Dakota
Pfizer Investigational Site
Fargo, North Dakota, United States, 58103
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45245
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77081
Pfizer Investigational Site
Houston, Texas, United States, 77074
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
San Antonio, Texas, United States, 78205
India
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 034
Pfizer Investigational Site
Karnal, Haryana, India, 132 001
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 003
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 043
Pfizer Investigational Site
Pune, Maharashtra, India, 411 030
Pfizer Investigational Site
Maharashtra, Mumbai, India, 400 007
Pfizer Investigational Site
Jaipur, Rajasthan, India, 302001
Pfizer Investigational Site
Chennai, Tamil Nadu, India, 600 029
Pfizer Investigational Site
Chennai, Tamil Nadu, India, 600 020
Malaysia
Pfizer Investigational Site
Kubang Kerian, Kelantan, Malaysia, 16150
Pfizer Investigational Site
Bandar Tasik Selatan, Kuala Lumpur, Malaysia, 57000
Pfizer Investigational Site
Ipoh, Perak, Malaysia, 30450
Pfizer Investigational Site
Taiping, Perak, Malaysia, 34000
Pfizer Investigational Site
Kuala Lumpur, Malaysia, 50603
Pfizer Investigational Site
Kuala Lumpur, Malaysia, 56000
Pfizer Investigational Site
Putrajaya, Malaysia, 62250
Puerto Rico
Pfizer Investigational Site
Toa Baja, Puerto Rico, 00949
Serbia
Pfizer Investigational Site
Belgrade, Serbia, 11 000
Pfizer Investigational Site
Belgrade, Serbia, 11000
Pfizer Investigational Site
Kragujevac, Serbia, 34 000
Pfizer Investigational Site
Nis, Serbia, 18000
Taiwan
Pfizer Investigational Site
Taichung, Taiwan
Pfizer Investigational Site
Tainan, Taiwan, 710
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 30, 2014