Who is sponsoring NCT01496430?

NCT01496430 is sponsored by Takeda.

What condition does NCT01496430 study?

NCT01496430 studies Hypertension, Diabetes.

What drugs are being tested in NCT01496430?

Interventions: Placebo, Azilsartan medoxomil, Azilsartan medoxomil.

What is the status of NCT01496430?

NCT01496430 is currently TERMINATED.

Last reviewed 2015-04-20 · How we verify

A Randomized, Double-Blind, Phase 3b Proof-of-Concept Study to Evaluate the Efficacy and Safety of TAK-491 Compared to Placebo When Used in Combination With Metformin in Subjects With Hypertension and Type 2 Diabetes

NCT01496430 Phase 3 TERMINATED Results posted

The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in stage 1 hypertensive, type 2 diabetes mellitus (T2DM) participants whose glycemic control was inadequate on metformin alone.

Details

Lead sponsor	Takeda
Phase	Phase 3
Status	TERMINATED
Enrolment	105
Start date	2012-01
Completion	2013-05

Conditions

Hypertension
Diabetes

Interventions

Placebo
Azilsartan medoxomil
Azilsartan medoxomil

Primary outcomes

Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure — Baseline and Week 8
The change in trough systolic blood pressure measured at week 8 relative to baseline. The trough is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.

Countries

United States