Aliskiren HCTZ Compared to Amlodipine in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus

Phase 4

Completed

• Conditions: Hypertension; Diabetes Mellitus
• Interventions: Drug: Hydrochlorothiazide (HCTZ); Drug: Amlodipine; Drug: Aliskiren

• Registration Number: NCT00787605
• Lead Sponsor: Novartis

Brief Summary

The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) given to diabetic patients with stage 2 systolic hypertension (mean sitting systolic blood pressure (msSBP) ≥ 160 mm Hg and \< 200 mm Hg).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-06
• Study First Posted: 2008-11-07
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2010-12-20
• Status Verified: 2011-05
• Results First Submitted QC: 2011-05-20
• Results First Posted: 2011-05-23
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 860

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aliskiren / HCTZ	Hydrochlorothiazide (HCTZ)	Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
Amlodipine	Amlodipine	Amlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks
Aliskiren / HCTZ	Aliskiren	Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)	Baseline and Week 8

Secondary Outcome Measures

Name	Time	Method
Biomarker Measurements	Baseline and Week 8	Geometric mean of the post to baseline ratio in biomarkers of plasma renin activity (ng/ml/h), plasma renin concentration (ng/L), and cystatin C (mg/L)
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)	Baseline and Week 8
Evaluate the Safety and Tolerability	after 8 weeks of treatment	Percentage of patients with Adverse Event and percentage of patients with edema
Percentage of Responders	Week 8	Response defined by mean sitting Systolic Blood Pressure \< 130 mm Hg or a reduction of mean sitting Systolic Blood Pressure \>= 20 mm Hg from baseline
Percentage of Patients Achieving Blood Pressure Control	after 8 weeks of treatment	Blood pressure control is defined as patient achieving a target Blood Pressure of mean sitting Systolic BloodPressure / mean sitting Diastolic Blood Pressure \< 130/80 mmHg.

Trial Locations

Locations (1)

Sites in USA; 🇺🇸 East Hanover, New Jersey, United States