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

March 26, 2010
April 10, 2013
May 2010
February 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01096667 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Safety and Efficacy Of PF-04971729 In Patients With Type 2 Diabetes And Hypertension
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Hypertension
  • Drug: Placebo
    Pills (n=3), 0 mg, once daily x 28-days
  • Drug: 1 mg PF-04971729
    pill (n=1), 1 mg strength + pills (n=2), 0 mg, all once daily x 28-days
  • Drug: 5 mg PF-04971729
    pill (n=1), 5 mg strength + pills (n=2), 0 mg, all once daily x 28-days
  • Drug: 25 mg PF-04971729
    pill (n=1), 25 mg strength + pills (n=2), 0 mg, all once daily x 28-days
  • Drug: 12.5mg HCTZ
    pill (n=1), 12.5 mg strength + pills (n=2), 0 mg, all once daily x 28-days
  • Placebo Comparator: Placebo
    Placebo for PF-04971729 and HCTZ
    Intervention: Drug: Placebo
  • Experimental: 1 mg PF-04971729
    1 mg PF-04971729
    Intervention: Drug: 1 mg PF-04971729
  • Experimental: 5 mg PF-04971729
    5 mg PF-04971729
    Intervention: Drug: 5 mg PF-04971729
  • Experimental: 25 mg PF-04971729
    25 mg PF-04971729
    Intervention: Drug: 25 mg PF-04971729
  • Active Comparator: 12.5mg HCTZ
    12.5mg hydrochlorothiazide (HCTZ)
    Intervention: Drug: 12.5mg HCTZ
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   India,   Malaysia,   Puerto Rico,   Serbia,   Taiwan
 
NCT01096667
B1521004
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP