Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00927394

Purpose

The purpose of the study is to evaluate the blood pressure (BP)-lowering efficacy of the combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy in Type II Diabetic patients with Stage II hypertension.

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren/Valsartan Drug: Valsartan	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	An 8 Week Randomized, Double-Blind, Parallel Group, Multi-Center, Active Controlled Study to Evaluate the Antihypertensive Efficacy and Safety of Aliskiren Administered in Combination With Valsartan Versus Valsartan Alone in Patients With Stage 2 Systolic Hypertension and Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Valsartan Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in MSSBP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in MSDBP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Percentage of patients achieving BP control (defined as MSSBP < 130 mmHg and MSDBP <80) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Percentage of responders (defined as patients with MSSBP <130 mmHg or a reduction from baseline in MSSBP of >20 mmHg) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change in MSSBP in patients with baseline MSSBP ≥180 mmHg and <200 mmHg and Type 2 diabetes mellitus [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Safety and tolerability of the combination of aliskiren and valsartan versus valsartan monotherapy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	422
Study Start Date:	May 2009
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Aliskiren 150/300mg and Valsartan 160/320mg (SPV100A)	Drug: Aliskiren/Valsartan Aliskiren 150 mg and 300mg Valsartan 160mg and 320mg
2: Active Comparator Valsartan 160/320mg	Drug: Valsartan Valsartan 160 mg and 320mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
Men or women 18 years and older.
Patients with Stage 2 systolic hypertension, defined as having a MSSBP ≥160 mmHg and <200 mmHg at Visit 5 (randomization).
Patients who have been newly diagnosed with hypertension or who have not received antihypertensive medication for at least 4 weeks (28 days) prior to Visit 1 must have MSSBP ≥ 160 mmHg and < 200 mmHg at Visit 1, otherwise, they will be considered screen failures.
Patients receiving antihypertensive medication must have a MSSBP of ≥150 mmHg and <200 mmHg at Study Visit 1, otherwise they will be considered screen failures.
Patients with Type 2 diabetes mellitus with an HbA1c ≤ 9 % at visit 1 and on a stable anti-diabetic regimen not including insulin or stable diet and exercise for at least 4 weeks prior to visit 1.

Exclusion Criteria:

Office blood pressure measured by cuff (MSSBP ≥200 mmHg or MSDBP ≥120 mmHg).
History or evidence of secondary hypertension of any etiology.
Refractory hypertension, defined as having uncontrolled BP (≥140/90 mmHg) while receiving 3 antihypertensive medications at the maximum approved dose of each drug, one of which must be a diuretic.
Patients treated with more than 3 antihypertensive medications (each component of a combination drug counts individually).
Type 2 diabetes mellitus currently requiring insulin treatment.
MDRD estimated GFR (eGFR) < 60 mL/min/1.73m2
Serum sodium less than lower limit of normal, serum potassium < 3.5 mEq/L or ≥ 5.3 mEq/L at Visit 1.
Known Keith-Wagener grade III or IV hypertensive retinopathy.
Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927394

Locations

United States, Delaware
Investigative Site
Newark, Delaware, United States, USA
United States, Missouri
Investigative Site
Kansas, Missouri, United States
United States, New Jersey
Investigative Site
Camden, New Jersey, United States
United States, Pennsylvania
Investigative Site
Philadelphia, Pennsylvania, United States

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CSPV100AUS02
Study First Received:	June 24, 2009
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00927394 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension, Type II Diabetes, Aliskiren, Valsartan,
Systolic blood pressure, Diastolic blood pressure,
Stage II, Combination

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Therapeutic Uses
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010