Expired Study
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East Hanover, New Jersey 07936


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.


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.


Study is Available At:


Original ID:

CSPP100A2309


NCT ID:

NCT00219115


Secondary ID:


Study Acronym:


Brief Title:

A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive


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 Resp


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

493


Enrollment Type:

Actual


Overall Contact Information

Official Name:Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Study Dates

Start Date:January 2005
Completion Date:March 2006
Completion Type:Actual
Primary Completion Date:March 2006
Primary Completion Type:Actual
Verification Date:November 2016
Last Changed Date:November 15, 2016
First Received Date:September 12, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change from baseline in mean sitting diastolic blood pressure after 8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in mean sitting systolic blood pressure after 8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Evaluate number mean sitting systolic/diastolic response from baseline to weeks 4 and 8
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after week 8
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Achieve mean sitting blood pressure control target of < 140/90 mmHg after week 8
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:aliskiren

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Jordan J, Engeli S, Boye SW, Le Breton S, Keefe DL. Direct Renin inhibition with aliskiren in obese patients with arterial hypertension. Hypertension. 2007 May;49(5):1047-55.
PMID:17353513

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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