A Clinical Study With Aliskiren Alone or in Combination Therapy With Diuretic Hctz in Venezuelan Hypertensive Patients.

NCT01056731 | Completed Phase 4 DMC

• 1 other identifier: CSPP100AVE01
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 7

Brief Summary

This is an open-label, not controlled, sequential, dose escalation study of 16 weeks' duration. The study is composed of two periods: a 0-2 week optional wash-out period depending on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment period. Patients will be evaluated every 4 weeks during period 2. Treatment will start with Aliskiren 150 mg with dose titration to Aliskiren 300 mg, and addition of HCTZ 12,5 mg and 25 if control of BP is not achieved (\< 140/90 mmHg or 130/ 80 mmHg in diabetics patients). All patients who have reached their BP target will be considered as having met the primary endpoint and this visit will be considered as the final visit.

Conditions

High Blood Pressure

Keywords

high blood pressure; aliskiren; hydrochlorothiazide; control rate

Outcome Measures

Primary Outcomes (1)

• The proportion of patients in whom BP control was achieved at the study end point

  16 weeks

Secondary Outcomes (4)

• The proportion of patients in whom BP control was reached before the addition of HCTZ (ie, at the pre-HCTZ end point

  8 weeks

• Percentage of patients achieving overall BP, DBP, an SBP control rate at week 4, 8, 12 and 16.

  16 weeks

• Change in msSPA and msDBP from baseline to different time points

  4,8,12 and 16 weeks

• Safety of Aliskiren therapy at different time points

  4,8,12 and 16 weeks

Study Arms (1)

Aliskiren and Aliskiren_HCTZ

EXPERIMENTAL

aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg 25 mg

Drug: Aliskiren and HCTZ

Interventions

Aliskiren and HCTZ DRUG

Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg

Aliskiren and Aliskiren_HCTZ

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients, with essential hypertension, stage I-II, naïve or not controlled with monotherapy.

You may not qualify if:

• BP\> 180/110 mmHg
• Pregnant or nursing women
• Hypertensive encephalopathy or cerebrovascular accident, transient ischemic - cerebral attack, myocardial infarction, unstable angina, coronary bypass surgery, percutaneous coronary intervention within 6 month
• K \<3.5 mEq/L or ≥ 5 mEq/L
• Renal impairment
• Hypersensitivity to HCTZ or Aliskiren or angioedema due to ACE-I or ARB

Sponsors & Collaborators

• Novartis: lead

Study Sites (7)

Investigative Site

Bolíva, Venezuela

Location

Investigative Site

Carabobo, Venezuela

Location

Investigative Site

Caracas, Venezuela

Location

Investigative Site

Edo Zulia, Venezuela

Location

Investigative Site

Estado Monagas, Venezuela

Location

Investigative Site

Falcón, Venezuela

Location

Investigative Site

Maracaibo Estado Zulia, Venezuela

Location

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 26, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

VE (7)