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

NCT00787605 | Completed Phase 4 Results

• 1 other identifier: CSPP100A2409
• Study Type: interventional
• Target: 860
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension; Diabetes Mellitus

Keywords

Hypertension, diabetes mellitus, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, amlodipine, stage 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

  Baseline and Week 8

Secondary Outcomes (5)

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

  Baseline and Week 8

• Percentage of Responders

  Week 8

• Percentage of Patients Achieving Blood Pressure Control

  after 8 weeks of treatment

• Biomarker Measurements

  Baseline and Week 8

• Evaluate the Safety and Tolerability

  after 8 weeks of treatment

Study Arms (2)

Amlodipine

ACTIVE COMPARATOR

Amlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks

Drug: Amlodipine

Aliskiren / HCTZ

EXPERIMENTAL

Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks

Drug: Hydrochlorothiazide (HCTZ); Drug: Aliskiren

Interventions

Amlodipine DRUG

Amlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks

Amlodipine

Hydrochlorothiazide (HCTZ) DRUG

Hydrochlorothiazide 12.5 mg for 1 week followed by Hydrochlorothiazide 25 mg for 7 weeks

Aliskiren / HCTZ

Aliskiren DRUG

Aliskiren 150 mg for 1 week followed by Aliskiren 300 mg for 7 weeks

Aliskiren / HCTZ

Eligibility Criteria

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

You may qualify if:

• Male or female outpatients ≥ 18 years old.
• Patients with a diagnosis of stage 2 hypertension (defined as an office cuff msSBP ≥ 160 mmHg and \< 200 mmHg) at Visit 5 (randomization).
• Patients with diabetes mellitus (Type 2) with an HbA1c at visit 1 ≤ 9.0 % and currently on stable anti-diabetic regimen or stable diet and exercise for at least 4 weeks prior to visit 1.
• Patients who are eligible and able to participate in the study, and who are willing to give written informed consent before any assessment is performed.

You may not qualify if:

• Office blood pressure measured by cuff (msSBP ≥ 200 mmHg or msDBP ≥ 110 mmHg) at Visits 1-5.
• History or evidence of secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheochromocytoma).
• History of hypertensive encephalopathy or heart failure (NYHA Class II-IV).
• Cerebrovascular accident, transient ischemic cerebral attack (TIA), coronary bypass surgery, myocardial infarction or any percutaneous coronary intervention (PCI) within 1 year prior to Visit 1.
• Serum sodium less than the lower limit of normal, serum potassium \< 3.5 mEq/L (corresponding to 3.5 mmol/L) or ≥ 5.3 mEq/L (corresponding to 5.3 mmol/L), or dehydration at Visit 1.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL).
• Use of other investigational drugs within 30 days of enrollment.
• History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (thiazide diuretics, renin inhibitors, calcium channel blockers, or dihydropyridine like calcium channel blockers) as the study drugs.
• History of gouty arthritis.
• Long QT syndrome or QTc \> 450 msec for males and \> 470 msec for females at screening.
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.
• Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
• Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL (and estradiol\< 20 pg/mL) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
• Known Keith-Wagener grade III or IV hypertensive retinopathy.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Sites in USA

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Interventions

Amlodipine; Hydrochlorothiazide; aliskiren

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 7, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 27, 2016
• Results First Posted: May 23, 2011

Record last verified: 2011-05

Locations

US (1)