A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive to HCTZ 25 mg - Full Text View

Purpose

To evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and HCTZ 25 mg in obese patients with essential hypertension inadequately treated with HCTZ 25 mg, compared to irbesartan or amlodipine with HCTZ or HCTZ alone.

Condition	Intervention	Phase
Hypertension	Drug: aliskiren	Phase III

MedlinePlus related topics:

High Blood Pressure Obesity

Drug Information available for:

Hydrochlorothiazide Amlodipine Amlodipine besylate Aliskiren Irbesartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A 12-Week Randomized Double-Blind Parallel Group Study to Evaluate the Efficacy and Safety of the Combination Aliskiren With HCTZ Compared to Irbesartan or Amlodipine With HCTZ or HCTZ Alone in Hypertensive Patients With BMI ≥ 30 kg/m2 Not Adequately Responsive to HCTZ 25 mg

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in mean sitting diastolic blood pressure after 8 weeks

Secondary Outcome Measures:

Change from baseline in mean sitting systolic blood pressure after 8 weeks
Evaluate number mean sitting systolic/diastolic response from baseline to weeks 4 and 8
Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after week 8
Achieve mean sitting blood pressure control target of < 140/90 mmHg after week 8

Estimated Enrollment:	496
Study Start Date:	January 2005

Eligibility

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

Criteria

Inclusion Criteria

Patients with essential hypertension
Patients with body mass index ≥ 30 kg/m2

Exclusion Criteria

Severe hypertension
History or evidence of a secondary form of hypertension
History of Hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined inclusion exclusion criteria also apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219115

Locations


United States, New Jersey
	Novartis Pharmaceuticals
	East Hanover, New Jersey, United States, 07936

Germany

	Investigative Centers, Germany

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

Study ID Numbers:	CSPP100A2309
First Received:	September 12, 2005
Last Updated:	November 9, 2006
ClinicalTrials.gov Identifier:	NCT00219115
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension, aliskiren, blood pressure, irbesartan, amlodipine, hydrochlorothiazide

Study placed in the following topic categories:

Obesity

Irbesartan

Vascular Diseases

Angiotensin II

Hydrochlorothiazide

Amlodipine

Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers

Membrane Transport Modulators

Vasodilator Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Calcium Channel Blockers

Cardiovascular Diseases

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00219115