Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety

Chongqing Medical University

Status and phase: Unknown; Phase 4

Conditions: Hypertension; Anxiety

Treatments: Drug: Tandospirone + Amlodipine placebo; Drug: Tandospirone placebo + Amlodipine placebo; Drug: Tandospirone placebo + Amlodipine; Drug: Tandospirone + Amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT03667677

CES-TAHA

Details and patient eligibility

About

This study compares the antihypertensive effects between different treatment groups including antihypertensive drug, anxiolytic, and both, which provide a new clinical evidence for controlling blood pressure in patients with hypertension and anxiety.

Full description

In recent years, many studies have found that elevated blood pressure is associated with anxiety. It has been report that the incidence of hypertension with anxiety is 25%-54%. The studies have confirmed that anxiety can significantly reduce the antihypertensive effect. Therefore, anxiolytics can increase the antihypertensive effect in patients with hypertension and anxiety. However, there is currently no standard treatment for patients with hypertension and anxiety, and few clinical studies have focused on the treatment of these neglected patients. Improvement on hypertension through relieving anxiety and relief of anxiety through lowering hypertension are lack of clinical studies to prove. This study compares the antihypertensive effects between different treatment groups including antihypertensive drug, anxiolytic, and both, which provide a new clinical evidence for controlling blood pressure in patients with hypertension and anxiety.

Enrollment: 256 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. An age of 60 - 80 years old;
2. Mild or moderate hypertension diagnosed in previous or at screening (office systolic blood pressure ≥ 140 mm Hg and ≤ 180 mm Hg, or diastolic blood pressure ≥ 90 mm Hg and ≤ 110 mm Hg, or both, on three readings on separate days when not taking any blood pressure drugs) ,and the blood pressure still meet the above criteria after the run-in period;
3. A total score ≥ 14 and ≤ 24 on the Hamilton Anxiety Scale (HAMA), except for panic disorder;
4. Informed consent signed.

Exclusion criteria

1. Secondary hypertension;
2. Office systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≤ 110 mm Hg
3. Hypertension with target organ damage;
4. Cerebral hemorrhage, ischemic cerebral infarction, coronary artery disease, myocardial infarction, second-degree or third-degree atrioventricular block, sick sinus syndrome, atrial fibrillation, left ventricular hypertrophy, cardiac insufficiency (NYHA class Ⅱ-Ⅳ);
5. Diabetes and dyslipidemia;
6. Asthma, chronic obstructive pulmonary disease, bronchiectasis, and respiratory failure;
7. Inflammatory bowel disease, active gastritis, pancreatitis, partial or complete intestinal obstruction, and chronic diarrhea;
8. Acute or chronic hepatitis, hepatic insufficiency (ALT or AST is more than 2 times the upper limit of normal), and renal insufficiency (serum creatinine > 130 umol / L);
9. Uncontrolled thyroid diseases;
10. Severe or unstable central nervous system diseases;
11. Schizophrenia, bipolar disorder, severe intellectual disability, or severe cognitive impairment;
12. Having been diagnosed with alcohol or drug abuse within the past 1 year;
13. Presenting the risk of suicide, self-injury, and hurt others;
14. Having participated in other clinical studies within the past 3 months;
15. Having been treated with anxiolytics, antidepressants, antipsychotics within the past 4 weeks, or have contraindications to the study medications.
16. Breastfeeding, pregnancy, or a pregnancy plan during the study;
17. Other diseases which the responsible clinician judged that a change in current therapy would place the participant at risk.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

256 participants in 4 patient groups, including a placebo group

Group 1

Experimental group

Description:

Tandospirone + Amlodipine

Treatment:

Drug: Tandospirone + Amlodipine

Group 2

Experimental group

Description:

Tandospirone placebo + Amlodipine

Treatment:

Drug: Tandospirone placebo + Amlodipine

Group 3

Experimental group

Description:

Tandospirone + Amlodipine placebo

Treatment:

Drug: Tandospirone + Amlodipine placebo

Group 4

Placebo Comparator group

Description:

Tandospirone placebo + Amlodipine placebo

Treatment:

Drug: Tandospirone placebo + Amlodipine placebo